Tapentadol Hydrochloride

The increasing cases of peripheral neuropathic pain, rise in screening for diabetic neuropathic pain among diabetics, increase in the geriatric population, and launch of new approved drugs, among other reasons are likely to fuel the growth of the peripheral neuropathic pain market size during the forecast period (2024–2034). LAS VEGAS, Aug. 28, 2024 /PRNewswire/ --DelveInsight's Peripheral Neuropathic Pain Market Insights report includes a comprehensive understanding of current treatment practices, peripheral neuropathic pain emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Peripheral Neuropathic Pain Market Report According to DelveInsight's analysis, the market size for peripheral neuropathic pain was found to be ~ USD 12 billion in the 7MM in 2023. The United States accounts for the largest market size of PNP in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan. The total cases of peripheral neuropathic pain in the 7MM were approximately 60 million cases in 2023, which are expected to increase during the study period (2020–2034). Leading peripheral neuropathic pain companies such as Lexicon Pharmaceuticals, Merz Therapeutics, Apurano Pharmaceuticals, Vertex Pharmaceuticals, WEX Pharmaceuticals, Scilex Holding Company, and others are developing novel peripheral neuropathic pain drugs that can be available in the peripheral neuropathic pain market in the coming years. The promising peripheral neuropathic pain therapies in the pipeline include LX9211, XEOMIN (incobotulinumtoxinA), Adezunap (AP707), Suzetrigine (VX-548), HALNEURON (Tetrodotoxin or TTX), SEMDEXA (SP-102), and others. Compared to all the emerging therapies, LX9211 and SEMDEXA are expected to become the market leader, having a major influence on the peripheral neuropathic pain market of the 7MM by 2034. In November 2023, Lexicon Pharmaceuticals announced that it has enrolled the first patient in PROGRESS (A Phase IIb, dose-ranging, randomized, double-blind, placebo-controlled, parallel-group, multicenter study with an open-label extension in patients with diabetic peripheral neuropathic pain) studying LX9211. Discover which therapies are expected to grab the major peripheral neuropathic pain market share @ Peripheral Neuropathic Pain Market Report Peripheral Neuropathic Pain Overview Peripheral neuropathies refer to conditions affecting peripheral nerve cells and fibers, arising from a variety of underlying causes. These nerves include the cranial nerves, spinal nerve roots and ganglia, nerve trunks and divisions, and the autonomic nervous system nerves. Peripheral neuropathies can be classified in several ways, such as mononeuropathies, multifocal neuropathies, and polyneuropathies. Mononeuropathy involves damage to a single nerve, while multiple mononeuropathy affects two or more nerves in different locations. Polyneuropathy typically impacts many or most nerves. The diversity of symptoms associated with peripheral neuropathy allows for the identification of distinct clinical phenotypes, which is important for guiding the diagnostic process. Nerve conduction studies are crucial for determining the phenotype and assessing severity. Additional diagnostic tools, such as laboratory tests, genetic testing, cerebrospinal fluid examination, nerve imaging, and nerve biopsy, may be useful in specific clinical situations. Peripheral Neuropathic Pain Epidemiology Segmentation The peripheral neuropathic pain epidemiology section provides insights into the historical and current peripheral neuropathic pain patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The peripheral neuropathic pain market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Cases of PNP Type-specific Cases of PNP Treated Cases of PNP Peripheral Neuropathic Pain Treatment Market The treatment of peripheral neuropathic pain depends on the underlying cause and the severity of symptoms. Initial management typically involves conservative measures, including medications such as NSAIDs, acetaminophen, and, in more severe cases, opioids. For radicular symptoms, neuroleptic agents may be used, and systemic steroids are sometimes prescribed for acute low back pain. Nonpharmacological treatments like physical therapy, acupuncture, chiropractic manipulation, and traction are also employed, though their effectiveness is debated. Interventional procedures, such as epidural steroid injections and percutaneous disc decompression, are commonly performed, while surgical options like decompression and spinal fusion are considered for cases that do not respond to other treatments. Pain management for PNP also includes the use of drugs such as NSAIDs, anticonvulsants, and antidepressants, with specific medications like QUTENZA, NUCYNTA ER, and TARLIGE approved for certain patient groups. TARLIGE (mirogabalin besylate) is an oral gabapentinoid developed by Daiichi Sankyo to treat peripheral neuropathic pain (PNP), including diabetic PNP and postherpetic neuralgia. In January 2019, Daiichi Sankyo announced that TARLIGE received approval for marketing in Japan for PNP treatment, offering patients in Japan a new therapeutic option for managing PNP. NUCYNTA ER (tapentadol) is an opioid agonist available as an extended-release film-coated tablet for oral use. It is prescribed for managing neuropathic pain related to diabetic peripheral neuropathy (DPN). In August 2012, the US FDA approved a sNDA for NUCYNTA ER, allowing it to be used as an oral analgesic taken twice daily to manage neuropathic pain in adults with DPN when ongoing, around-the-clock opioid treatment is required for a prolonged duration. The QUTENZA (capsaicin) 8% topical system delivers capsaicin through a localized dermal application. Capsaicin acts as an agonist for the TRPV1 receptor. In July 2020, Grünenthal's US subsidiary, Averitas Pharma, obtained FDA approval for the QUTENZA 8% patch to treat neuropathic pain related to diabetic peripheral neuropathy in the feet of adults. To know more about peripheral neuropathic pain treatment guidelines, visit @ Peripheral Neuropathic Pain Management Peripheral Neuropathic Pain Pipeline Therapies and Key Companies LX9211: Lexicon Pharmaceuticals XEOMIN (IncobotulinumtoxinA): Merz Therapeutics Adezunap (AP707): Apurano Pharmaceuticals Suzetrigine (VX-548): Vertex Pharmaceuticals HALNEURON (Tetrodotoxin or TTX): WEX Pharmaceuticals SEMDEXA (SP-102): Scilex Holding Company Discover more about peripheral neuropathic pain drugs in development @ Peripheral Neuropathic Pain Clinical Trials Peripheral Neuropathic Pain Market Dynamics The peripheral neuropathic pain market dynamics are expected to change in the coming years. Emerging disease-modifying therapies for diabetic neuropathy, CIPN, and LSR are gaining attention due to the growing prevalence of cancer, increased chemotherapy usage, and the large patient pool in need of pain management. The lack of disease-modifying treatment options in the current landscape, which relies solely on symptomatic relief, highlights the market potential for these therapies. Recent developmental activities targeting novel pathways, such as adapter-associated kinase 1 (AAK1) and the Nav1.8 voltage-gated sodium channel, aim to provide opioid-free pain relief, which could lead to a high uptake and the ability to charge a premium price. Furthermore, potential therapies are being investigated for the treatment of peripheral neuropathic pain, and it is safe to predict that the treatment space will significantly impact the peripheral neuropathic pain market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the peripheral neuropathic pain market in the 7MM. However several factors may impede the growth of the peripheral neuropathic pain market. The management of DPN is challenging due to the persistent and severe nature of neuropathic pain, which is frequently ineffectively treated and negatively impacts the quality of life, further complicated by pharmacogenetic and genetic variations in patients; additionally, while improving glycemic control in Type-2 diabetes remains uncertain, the availability of low-cost generics in the treatment landscape may significantly hamper the uptake of emerging therapies, increasing the burden and associated health costs. Moreover, peripheral neuropathic pain treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, peripheral neuropathic pain market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact peripheral neuropathic pain market growth. Scope of the Peripheral Neuropathic Pain Market Report Therapeutic Assessment: Peripheral Neuropathic Pain current marketed and emerging therapies Peripheral Neuropathic Pain Market Dynamics: Key Market Forecast Assumptions of Emerging Peripheral Neuropathic Pain Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Peripheral Neuropathic Pain Market Access and Reimbursement Download the report to understand which factors are driving peripheral neuropathic pain market trends @ Peripheral Neuropathic Pain Market Trends Table of Contents Related Reports Peripheral Neuropathic Pain Epidemiology Forecast Peripheral Neuropathic Pain Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the Peripheral Neuropathic Pain epidemiology trends. Peripheral Neuropathic Pain Pipeline Peripheral Neuropathic Pain Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Peripheral Neuropathic Pain companies, including Haisco Pharmaceutical Group, GlaxoSmithKline, Algiax Pharmaceuticals, Apurano Pharmaceuticals GmbH, Eli Lilly and Company, Shanghai SIMR Biotechnology, Lexicon Pharmaceuticals, among others. Diabetic Neuropathy Market Diabetic Neuropathy Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key diabetic neuropathy companies, including Novo Nordisk, Ionis Pharmaceuticals, Pfizer, Regeneron, NeuroMetrix, among others. Diabetic Neuropathy Pipeline Diabetic Neuropathy Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key diabetic neuropathy companies, including Goldfinch Bio, Novartis, Serodus, CURACLE, Daiichi Sankyo, NeuroBo Pharmaceuticals, Dong-A Pharmaceutical , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP

STOUGHTON, Mass., Aug. 28, 2024 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL), a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions, today announced that eight poster presentations highlighting data regarding its diversified pain portfolio will be presented at PAINWeek Conference 2024, being held in Las Vegas, NV, from September 3–6, 2024. “Collegium is proud to present new real-world data at PAINWeek 2024 as part of our commitment to leading with science and responsible pain management,” said Thomas Smith, M.D., Chief Medical Officer of Collegium. “The eight posters demonstrate the clinical and population health impact of our meaningfully differentiated pain portfolio and provide important insights for healthcare decision makers who treat people with pain. We welcome opportunities to share clinical and real-world data with the medical community as we advance our mission to improve the lives of people living with serious medical conditions.” The following posters will be available and on display to attendees in the Exhibit Hall from 10:30 a.m. PT on Wednesday, September 4, 2024, to 2:45 p.m. PT on Friday, September 6, 2024. Poster Presentations: Poster Title:Healthcare Costs and Resource Use among Chronic Low Back Pain Patients Treated with Belbuca® or Buprenorphine Transdermal Patches: A Retrospective US Medicare Claims AnalysisAuthors:Vladimir Zah, D.Phil.; Filip Stanicic, M.Pharm, MSC; Dimitrije Grbic, M.Pharm., Ph.D. Poster Title:Treatment Characteristics and Dosing Patterns in Chronic Low Back Pain Patients Treated with Belbuca® and Buprenorphine Transdermal Patches: A Retrospective US Medicare Claims AnalysisAuthors:Filip Stanicic, M.Pharm., MSC; Vladimir Zah, D.Phil,; Dimitrije Grbic, M.Pharm., Ph.D. Poster Title:Safety and Tolerability of Schedule III Buprenorphine and Oral Schedule II Opioid Treatment in Chronic Low Back Pain Patients: A Retrospective US Medicare Claims AnalysisAuthors:Dimitrije Grbic, M.Pharm., Ph.D.; Filip Stanicic, M.Pharm., MSC; Vladimir Zah, D.Phil, Poster Title:Comparison of Nonmedical Use of Buprenorphine Products for Analgesia Compared to Other Opioid Medications in Adults Evaluated for Substance Use with the Addiction Severity Index-Multimedia Version (ASI-MV®)Authors:Jody Green, Ph.D.; Kaitlin Hartlage, MPH; Taryn Dailey-Govoni, MPH; Suzanne Vosburg, Ph.D. Poster Title:Exposures Reported to US Poison Centers Involving Buprenorphine Products for Analgesia Compared to Other Opioid MedicationsAuthors:Jody Green, Ph.D.; Kaitlin Hartlage, MPH; Taryn Dailey-Govoni, MPH; Suzanne Vosburg, Ph.D. Poster Title:A Review of the Primary and Secondary Outcomes From a Phase I Study Comparing the Respiratory Effects of Buprenorphine Buccal Film and Oral Oxycodone Hydrochloride AdministrationAuthors:Lynn Webster, M.D.; Matthew Maga, Ph.D. Poster Title:Nonmedical Use and Route of Administration of XTAMPZA® ER versus Other Oxycodone Medications (Extended- and Immediate-Release) in Adults Evaluated for Substance Use with the Addiction Severity Index-Multimedia Version (ASI-MV®)Authors:Jody Green, Ph.D.; Kaitlin Hartlage, MPH; Taryn Dailey-Govoni, MPH; Suzanne Vosburg, Ph.D. Poster Title:Curbing Opioid Abuse: Real-World Evidence of Abuse-Deterrent FormulationsAuthors:Lynn Webster, M.D.; Jeff Gudin, M.D. For more information on PAINWeek Conference 2024, visit: https://www.painweek.org/. Xtampza® ER (oxycodone) extended-release capsules, CII, Nucynta® ER (tapentadol) extended-release tablets, CII, and Nucynta® (tapentadol) tablets, CII, can be abused or misused, and carry a risk of addiction. These products are intended for use only in appropriate pain patients and only when other treatment alternatives are inadequate. Use of Xtampza® ER, Nucynta® ER and Nucynta® can result in serious, life-threatening or fatal respiratory depression, even when used exactly as prescribed. See Important Safety Information, including Boxed Warning on addiction, abuse, and misuse and other serious risks regarding each of these three products at the end of this press release. About Collegium Pharmaceutical, Inc. Collegium is a leading, diversified specialty pharmaceutical company committed to improving the lives of people living with serious medical conditions. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the Company’s website at www.collegiumpharma.com. INDICATIONS AND USAGE Xtampza® ER (oxycodone) is: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid when other pain treatments, such as non-opioid pain medicines or immediate-release opioid medicines, do not treat your pain well enough or you cannot tolerate them.A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed by your healthcare provider, you are at risk for opioid addiction, abuse, and misuse that can lead to death.Not for use to treat pain that is not around-the-clock. IMPORTANT SAFETY INFORMATION ABOUT XTAMPZA ER WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTSAddiction, Abuse, and MisuseXtampza ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing Xtampza ER and monitor all patients regularly for the development of these behaviors or conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program,counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, andconsider other tools to improve patient, household, and community safety. Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of Xtampza ER. Monitor for respiratory depression, especially during initiation of Xtampza ER or following a dose increase.Accidental IngestionAccidental ingestion of even one dose of Xtampza ER, especially by children, can result in a fatal overdose of oxycodone.Neonatal Opioid Withdrawal SyndromeProlonged use of Xtampza ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Cytochrome P450 3A4 InteractionThe concomitant use of Xtampza ER with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving Xtampza ER and any CYP3A4 inhibitor or inducer.Risks From Concomitant Use With Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of Xtampza ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.Limit dosages and durations to the minimum required.Follow patients for signs and symptoms of respiratory depression and sedation. Important information about Xtampza ER: Get emergency help or call 911 right away if you take too much Xtampza ER (overdose). When you first start taking Xtampza ER, when your dose is changed, or if you take too much (overdose), serious life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an overdose.Taking Xtampza ER with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.Never give anyone else your Xtampza ER. They could die from taking it. Selling or giving away Xtampza ER is against the law.Store Xtampza ER securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not take Xtampza ER if you have: severe asthma, trouble breathing, or other lung problems.a bowel blockage, or have narrowing of the stomach or intestines. Before taking Xtampza ER, tell your healthcare provider if you have a history of: head injury, seizuresliver, kidney, thyroid problemsproblems urinatingpancreas or gallbladder problemsabuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems Tell your healthcare provider if you are: pregnant or planning to become pregnant. Prolonged use of Xtampza ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.breastfeeding. Not recommended during treatment with Xtampza ER. It may harm your baby.living in a household where there are small children or someone who has abused street or prescription drugs.taking prescription or over-the counter medicines, vitamins, or herbal supplements. Taking Xtampza ER with certain other medicines can cause serious side effects that could lead to death. When taking Xtampza ER: Do not change your dose. Take Xtampza ER exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.Take your prescribed dose every 12 hours, at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.If you cannot swallow Xtampza ER capsules, see the detailed Instructions for Use in the Medication Guide.Always take Xtampza ER capsules with approximately the same amount of food to ensure enough medicine is absorbed.Swallow Xtampza ER whole. Do not snort, or inject Xtampza ER because this may cause you to overdose and die.The contents of the Xtampza ER capsules may be sprinkled on soft food, sprinkled into a cup and then put directly into the mouth, or given through a nasogastric or gastrostomy tube.Call your healthcare provider if the dose you are taking does not control your pain.Do not stop taking Xtampza ER without talking to your healthcare provider.Dispose of expired, unwanted or unused Xtampza ER by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. While taking Xtampza ER, DO NOT: Drive or operate heavy machinery, until you know how Xtampza ER affects you. Xtampza ER can make you sleepy, dizzy, or light-headed.Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Xtampza ER may cause you to overdose and die. The possible side effects of Xtampza ER are: constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, and abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe. Get emergency medical help or call 911 right away if you have: trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion. These are not all the possible side effects of Xtampza ER. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. For more information, go to dailymed.nlm.nih.gov. See full Prescribing Information, including Boxed Warning on Addiction, Abuse and Misuse and other serious risks, and the Medication Guide accompanying this piece or at XtampzaER.com/PI. Speak to your healthcare provider if you have questions about Xtampza ER. APPROVED USE BELBUCA® (buprenorphine buccal film) CIII is: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.A long-acting opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.Not for use to treat pain that is not around-the-clock. IMPORTANT SAFETY INFORMATION about BELBUCA® WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND OTHER CNS DEPRESSANTSAddiction, Abuse, and MisuseBELBUCA exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing BELBUCA, and monitor regularly for these behaviors and conditions.Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program,counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, andconsider other tools to improve patient, household, and community safety. Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of BELBUCA. Monitor for respiratory depression, especially during initiation of BELBUCA or following a dose increase. Misuse or abuse of BELBUCA by chewing, swallowing, snorting, or injecting buprenorphine extracted from the buccal film will result in the uncontrolled delivery of buprenorphine and poses a significant risk of overdose and death.Accidental ExposureAccidental exposure to even one dose of BELBUCA, especially in children, can result in a fatal overdose of buprenorphine.Neonatal Opioid Withdrawal SyndromeProlonged use of BELBUCA during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Risks from Concomitant Use with Benzodiazepines Or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. Important information about BELBUCA: Get emergency help or call 911 right away if you take too much BELBUCA (overdose). When you first start taking BELBUCA, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.Taking BELBUCA with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.Never give anyone else your BELBUCA. They could die from taking it. Selling or giving away BELBUCA is against the law.Store BELBUCA securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not use BELBUCA if you have: severe asthma, trouble breathing, or other lung problems.a bowel blockage or have narrowing of the stomach or intestines. Before taking BELBUCA, tell your healthcare provider if you have a history of: head injury, seizuresheart rhythm problems (long QT syndrome)liver, kidney, thyroid problemstooth problems, including a history of cavitiespancreas or gallbladder problemsproblems urinatingabuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems Tell your healthcare provider if you are: pregnant or planning to become pregnant. Prolonged use of BELBUCA during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.breastfeeding. Not recommended during treatment with BELBUCA. It may harm your baby.Living in a household where there are small children or someone who has abused street or prescription drugs.taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking BELBUCA with certain other medicines can cause serious side effects and could lead to death. When taking BELBUCA: Do not change your dose. Apply BELBUCA exactly as prescribed by your healthcare provider. Use the lowest effective dose possible for the shortest time needed.See the detailed Instructions for Use for information about how to apply BELBUCA.Do not apply BELBUCA if the package seal is broken or the film is cut, damaged, or changed in any way.After the film has adhered to your cheek, avoid eating or drinking until the film has completely dissolved, usually within 30 minutes.After BELBUCA is completely dissolved, rinse your mouth with water and swallow. Wait for at least one hour before brushing teeth.Report any problems with your teeth immediately to your healthcare provider and schedule an appointment with a dentist. Tell your dentist that you have started taking BELBUCA.Avoid touching or moving the buccal film with your tongue or fingers.Do not chew, swallow, snort or inject BELBUCA. This will result in uncontrolled delivery of buprenorphine and may cause you to overdose and die.Call your healthcare provider if the dose you are using does not control your pain.Do not stop using BELBUCA without talking to your healthcare provider.Dispose of expired, unwanted, or unused BELBUCA by removing the BELBUCA film from the foil packaging, and promptly flushing down the toilet (if a drug takeback option is not readily available). Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. While using BELBUCA DO NOT: Drive or operate heavy machinery, until you know how BELBUCA affects you. BELBUCA can make you sleepy, dizzy, or lightheaded.Drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with BELBUCA may cause you to overdose and die. The possible side effects of BELBUCA are: nausea, constipation, headache, vomiting, dizziness, and sleepiness. Call your healthcare provider if you have any of these symptoms and they are severe. Get emergency medical help or call 911 right away if you have: trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion. These are not all the possible side effects of BELBUCA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov. Please see full Prescribing Information, including Boxed Warning on Addiction, Abuse, and Misuse, and other serious risks, and Medication Guide or speak to your healthcare provider if you have questions about BELBUCA. INDICATIONS AND USAGE NUCYNTA® (tapentadol) tablets are: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage short term (acute) pain in adults and children 6 years of age and older who weigh at least 88 pounds (40 kg), when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death. IMPORTANT SAFETY INFORMATION ABOUT NUCYNTA TABLETS WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF NUCYNTA TABLETSAddiction, Abuse, and MisuseBecause the use of NUCYNTA tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess regularly for the development of these behaviors and conditions.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of NUCYNTA tablets, especially during initiation of NUCYNTA tablets or following a dose increase. To reduce the risk of respiratory depression, proper dosing and titration of NUCYNTA tablets are essential.Accidental IngestionAccidental ingestion of even one dose of NUCYNTA tablets, especially by children, can result in a fatal overdose of tapentadol.Risks From Concomitant Use With Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of NUCYNTA tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.Neonatal Opioid Withdrawal SyndromeIf opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of Neonatal Opioid Withdrawal Syndrome which may be life threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription. Important information about NUCYNTA tablets: Get emergency help or call 911 right away if you take too much NUCYNTA (overdose) tablets. When you first start taking NUCYNTA tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.Taking NUCYNTA tablets with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.Never give anyone else your NUCYNTA tablets. They could die from taking it. Selling or giving away NUCYNTA tablets is against the law.Store NUCYNTA tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not take NUCYNTA tablets if you have: severe asthma, trouble breathing, or other lung problems.a bowel blockage or have narrowing of the stomach or intestines. Before taking NUCYNTA tablets, tell your healthcare provider if you have a history of: head injury, seizuresproblems urinatingabuse of street or prescription drugs, alcohol addiction, opioid overdose or mental health problemsliver, kidney, thyroid problemspancreas or gallbladder problems Tell your healthcare provider if you: notice your pain getting worse. If your pain gets worse after you take NUCYNTA tablets, do not take more NUCYNTA tablets without first talking to your healthcare provider. Tell your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking NUCYNTA tablets.are pregnant or planning to become pregnant. Use of NUCYNTA tablets for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.are breastfeeding. NUCYNTA tablets pass into breast milk and may harm your baby.are living in a household where there are small children or someone who has abused street or prescription drugs.are taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking NUCYNTA tablets with certain other medicines can cause serious side effects that could lead to death. When taking NUCYNTA tablets: Do not change your dose. Take NUCYNTA tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.For acute (short-term) pain, you may only need to take NUCYNTA tablets for a few days. You may have some NUCYNTA tablets left over that you did not use. See disposal information at the bottom of this section for directions on how to safely throw away (dispose of) your unused NUCYNTA tablets.Take your prescribed dose every 4-6 hours, at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.Call your healthcare provider if the dose you are taking does not control your pain.If you have been taking NUCYNTA tablets regularly, do not stop taking NUCYNTA tablets without talking to your healthcare provider.Dispose of expired, unwanted, or unused NUCYNTA Tablets by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. While taking NUCYNTA tablets, DO NOT: Drive or operate heavy machinery, until you know how NUCYNTA tablets affect you. NUCYNTA tablets can make you sleepy, dizzy, or lightheaded.Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with NUCYNTA tablets may cause you to overdose and die. The possible side effects of NUCYNTA tablets: constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe. Get emergency medical help or call 911 right away if you have: trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion. These are not all of the possible side effects of NUCYNTA tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information, go to dailymed.nlm.nih.gov. See full Prescribing Information, including Boxed Warning on Addiction, Abuse and Misuse and other serious risks, and the Medication Guide accompanying this piece or at Nucynta.com/IRpi. Speak to your healthcare provider if you have questions about Nucynta. INDICATIONS AND USAGE NUCYNTA® ER (tapentadol) is: A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid when other pain treatments, such as non-opioid pain medicines or immediate-release opioid medicines, do not treat your pain well enough or you cannot tolerate them.Also used to manage pain from damaged nerves (neuropathic pain) that happens with diabetes and is severe enough to require daily, around-the-clock, long-term treatment with an opioid when other pain treatments, such as non-opioid pain medicines, do not treat your pain well enough or you cannot tolerate them.A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.Not used to treat pain that is not around-the-clock pain. IMPORTANT SAFETY INFORMATION ABOUT NUCYNTA ER WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTSAddiction, Abuse, and MisuseNUCYNTA ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing NUCYNTA ER, and monitor all patients regularly for the development of these behaviors and conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to complete a REMS-compliant education program,counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, andconsider other tools to improve patient, household, and community safety. Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of NUCYNTA ER. Monitor for respiratory depression, especially during initiation of NUCYNTA ER or following a dose increase. Instruct patients to swallow NUCYNTA ER tablets whole; crushing, chewing, or dissolving NUCYNTA ER tablets can cause rapid release and absorption of a potentially fatal dose of tapentadol.Accidental IngestionAccidental ingestion of even one dose of NUCYNTA ER, especially by children, can result in a fatal overdose of tapentadol.Neonatal Opioid Withdrawal SyndromeProlonged use of NUCYNTA ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Interaction With AlcoholInstruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking NUCYNTA ER. The co-ingestion of alcohol with NUCYNTA ER may result in increased plasma tapentadol levels and a potentially fatal overdose of tapentadol.Risks From Concomitant Use With Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of NUCYNTA ER and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.Limit dosages and durations to the minimum required.Follow patients for signs and symptoms of respiratory depression and sedation. Important information about NUCYNTA ER: Get emergency help or call 911 right away if you take too much NUCYNTA ER (overdose). When you first start taking NUCYNTA ER, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.Taking NUCYNTA ER with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.Never give anyone your NUCYNTA ER. They could die from taking it. Selling or giving away NUCYNTA ER Tablets is against the law.Store NUCYNTA ER Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not take NUCYNTA ER if you have: severe asthma, trouble breathing, or other lung problems.a bowel blockage or have narrowing of the stomach or intestines. Before taking NUCYNTA ER, tell your healthcare provider if you have a history of: head injury, seizuresproblems urinatingabuse of street or prescription drugs, alcohol addiction, opioid overdose or mental health problemsliver, kidney, thyroid problemspancreas or gallbladder problems Tell your healthcare provider if you are: pregnant or planning to become pregnant. Prolonged use of NUCYNTA ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.breastfeeding. Not recommended during treatment with NUCYNTA ER. It may harm your baby.living in a household where there are small children or someone who has abused street or prescription drugs.taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking NUCYNTA ER with certain other medicines can cause serious side effects. When taking NUCYNTA ER: Do not change your dose. Take NUCYNTA ER exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed.Take your prescribed dose every 12 hours, at the same time every day. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time.Swallow NUCYNTA ER whole. Do not cut, break, chew, crush, dissolve, snort, or inject NUCYNTA ER because this may cause you to overdose and die.Call your healthcare provider if the dose you are taking does not control your pain.Do not stop taking NUCYNTA ER without talking to your healthcare provider.Dispose of expired, unwanted, or unused NUCYNTA ER Tablets by promptly flushing down the toilet if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. While taking NUCYNTA ER DO NOT: Drive or operate heavy machinery until you know how NUCYNTA ER affects you. NUCYNTA ER can make you sleepy, dizzy, or lightheaded.Drink alcohol, or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with NUCYNTA ER may cause you to overdose and die. The possible side effects of NUCYNTA ER are: constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe. Get emergency medical help or call 911 right away if you have: trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.agitation, hallucinations, coma, feeling overheated, or heavy sweating. These are not all the possible side effects of NUCYNTA ER. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information, go to dailymed.nlm.nih.gov. See full Prescribing Information, including Boxed Warning on Addiction, Abuse and Misuse and other serious risks, and the Medication Guide accompanying this piece or at Nucynta.com/PI. Speak to your healthcare provider if you have questions about Nucynta ER. Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "forecasts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements related to our full-year 2024 financial guidance, including projected product revenue, adjusted operating expenses and adjusted EBITDA, current and future market opportunities for our products and our assumptions related thereto, expectations (financial or otherwise) and intentions, and other statements that are not historical facts. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results, performance, or achievements to differ materially from the company's current expectations, including risks relating to, among others: unknown liabilities; risks related to future opportunities and plans for our products, including uncertainty of the expected financial performance of such products; our ability to commercialize and grow sales of our products; our ability to manage our relationships with licensors; the success of competing products that are or become available; our ability to maintain regulatory approval of our products, and any related restrictions, limitations, and/or warnings in the label of our products; the size of the markets for our products, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and degree of market acceptance of our products; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for our products; the outcome of any patent infringement or other litigation that may be brought by or against us; the outcome of any governmental investigation related to our business; our ability to secure adequate supplies of active pharmaceutical ingredient for each of our products and manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding for our operations and business development; regulatory developments in the U.S.; our expectations regarding our ability to obtain and maintain sufficient intellectual property protection for our products; our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency, or DEA, compliance; our customer concentration; and the accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional financing. These and other risks are described under the heading "Risk Factors" in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other filings with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Investor Contact:Christopher James, M.D.Vice President, Investor Relationsir@collegiumpharma.com Media Contact:Marissa SamuelsVice President, Corporate Communicationscommunications@collegiumpharma.com