This phase III trial compares a smartphone application with or without nicotine replacement therapy in improving smoking cessation among Hispanic adults who would like to quit smoking. The iCanQuit smartphone application focuses on skills for managing urges, motivation, and relapse prevention with personalized quit plans. Nicotine replacement therapy works by giving small, steady doses of nicotine to help stop cravings and relieve symptoms that occur when a person is trying to quit smoking without any of the other harmful chemicals found in tobacco products.

Start Date01 Jun 2025

Sponsor / Collaborator

Fred Hutchinson Cancer Research Center

[+1]

NCT06334016

/ Not yet recruitingEarly Phase 1IIT

Acute Effects of Sequential Nicotine Vaping on the Pharmacokinetic and Pharmacodynamic Properties of Vaped THC: A Double-Blind, Placebo-Controlled, Randomized Within-Subject Crossover Study

This clinical trial assesses differences in the delivery of THC to the bloodstream depending on whether nicotine vapes are used before or after THC. While there has been much recent publicity about vaping products and concern about their safety considering their increasing use for THC administration, the THC delivery profile associated with THC liquid vaping products in human subjects is currently unknown. Importantly, how the delivery to the bloodstream of THC vaping liquids compare to delivery from smoked cannabis, which is the most used method of cannabis delivery, will serve as an important benchmark for evaluating the delivery and effects of THC vaping products, and their relative safety.

Start Date27 May 2025

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

[+1]

NCT06584929

/ Not yet recruitingNot ApplicableIIT

Evaluating Population-Based Strategies for Rural Smoking Cessation

Understanding ways to help people who live in rural areas quit smoking is a public health priority. quitting smoking among rural people who smoke is a critical public health concern. People in rural areas smoke at higher rates than those in urban areas, experience high rates of smoking caused cancers and deaths. We are recruiting rural people from around the country to better understand how different quit smoking methods can improve a person's chances of successfully quitting smoking.

Start Date01 May 2025

Sponsor / Collaborator

University of Minnesota Masonic Cancer Center

100 Clinical Results associated with Nicotine

100 Translational Medicine associated with Nicotine

100 Patents (Medical) associated with Nicotine

50,605

Literatures (Medical) associated with Nicotine

01 Sep 2025·TALANTA

A diverse paper sensor for the rapid determination of nicotine and cotinine traces in air, vaping liquid, and human saliva

Article

Author: Nihal, Serena ; Sarfo, Daniel ; Nihal, Aneel ; Izake, Emad L ; Sonar, Prashant ; Tesfamichael, Tuquabo ; Ayoko, Godwin

The smoking of nicotine and passive exposure to environmental tobacco smoke can lead to many chronic medical conditions such as respiratory, cardiovascular, and cancer diseases. Nicotine smoking can also cause complications for patients undergoing medical procedures. The prevalence of vaping among young people has added a significant challenge to the health care systems as many commercial vaping oils contain undeclared nicotine content, thus leading to nicotine addiction. Governments around the world criminalised the undeclared presence of nicotine in vaping oils. Therefore, there a is strong demand for new materials and sensors that can rapidly detect nicotine/tobacco smoke in vaping products and the environment. Similarly, there is an ongoing need for rapid methods to determine the concentration of the nicotine metabolite, cotinine, in patients prior to medical procedures. To address these needs, we have synthesised and utilised a cost-effective paper sensor for the rapid screening of nicotine and cotinine in vaping the oil, the gas phase, and the human saliva by surface-enhanced Raman spectroscopy (SERS). The new sensor can detect ultra traces of nicotine and cotinine down to 1 pg/mL and 1 ng/mL respectively, within 20 min. The new sensor can be recycled for repeated screening of nicotine and its metabolite, thus maximizing its economic viability. The was successfully utilised for the detection of nicotine in tobacco smoke and in spiked human saliva by a handheld Raman spectrometer, thus indicating its potential for real-life applications.

01 Sep 2025·ADDICTIVE BEHAVIORS

Patterns of substance use on a given day in a national sample of U.S. young adults

Article

Author: Patrick, Megan E ; Arterberry, Brooke J ; Lanza, Stephanie T ; Evans-Polce, Rebecca J

INTRODUCTION:

Young adulthood constitutes a period of substance use risk and many young adults engage in use of more than one substance. While existing work has examined young adult co-use of substances at the day-level, there has not been a comprehensive investigation of day-level substance use that considers mode and intensity of use in a national sample of U.S. young adults.

METHODS:

Individuals were eligible through participation in the nationally-representative Monitoring the Future study in 12th grade in 2018 and reporting past 30-day drinking in 12th-grade. Respondents completed a 14-day daily study in 2019 (n = 911 individuals; modal age 19). Days on which individuals reported alcohol, cannabis, and/or nicotine/tobacco use (n = 3,086 days and 590 individuals) were examined. Latent class analysis was used to identify patterns of substance use at the day-level with stress, boredom, loneliness, and type of day as covariates.

RESULTS:

Six patterns of substance use days were identified: Vaping Nicotine (33.69 %), Cannabis Smoking (23.49 %), Alcohol Only (17.10 %), Cannabis Vaping (11.72 %), Multiple Combustibles (7.28 %), and Multimodal Cannabis (6.72 %) days. Stress and boredom were greater on Multimodal Cannabis days compared to most other substance use days. Alcohol Only days were characterized by lower levels of stress, boredom, and loneliness and a greater probability of being a special occasion or a weekend compared to other substance use days.

DISCUSSION:

This study identified heterogeneous patterns of substance use behaviors among U.S. young adults. Understanding these patterns is important for developing intervention strategies that are responsive to specific substance use on a given day.

01 Aug 2025·ADDICTIVE BEHAVIORS

Switching between vaping devices, nicotine concentration, and flavors among people who use e-cigarettes daily: Results from a 12-Month longitudinal study

Article

Author: Martin, Connor D ; Kaiser, Lisa M ; Block, Ashleigh C ; Miller, Connor R ; Goniewicz, Maciej L

BACKGROUND:

E-cigarettes vary widely in product characteristics (e.g., device type, nicotine concentration, and flavor). Little is known about how people who use e-cigarettes switch between products with different characteristics. We tracked the stability/variability in characteristics of products used by individuals who vaped e-cigarettes daily over one year.

METHODS:

Of 126 enrolled participants who vaped e-cigarettes daily and did not use other nicotine products, 80 completed 12 monthly study visits. Participants reported device type, nicotine concentration, and flavors used in the past 30 days at each visit. Participants were also asked to bring e-cigarette devices and e-liquids to each visit. Study staff took pictures of products carried by participants and categorized product characteristics.

RESULTS:

Over one year, 35.0 % of participants did not change device type, nicotine concentration, or flavor type. However, 35 % of participants changed device type, 31.3 % changed nicotine concentration, and 46.3 % changed flavor at least once. The most common change in device type was switching from open to closed system devices (67.9 %). The rate of switching from low to high nicotine (≤24 vs. > 24 mg/mL) was more common than the reverse (56.6 % vs. 43.4 %). The most common change in flavor was switching between Fruit/Sweet and Hybrid (Fruit/Sweet with a cooling additive, 75.7 % of flavor switching events).

CONCLUSIONS:

Most study participants switched one product characteristic at least once during a 12-month study period. Users most frequently switched flavors and least frequently switched nicotine concentrations. Future studies should consider the variability of product use patterns among people who use e-cigarettes.

186

News (Medical) associated with Nicotine

15 May 2025

·www.globenewswire.com

Amneal Receives U.S. FDA Approval for Brekiya® (dihydroergotamine mesylate) injection for the Acute Treatment of Migraine and Cluster Headaches in Adults

Brekiya® becomes the first and only DHE autoinjector that allows patients to self-administer the same medication used in hospitals in a ready-to-use form Product will be available for appropriate patients in the second half of 2025 BRIDGEWATER, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved Brekiya® (dihydroergotamine mesylate) injection, the first and only dihydroergotamine (DHE) autoinjector for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.1,2 Brekiya autoinjector provides patients with the potential for sustained* pain relief† in a convenient, self-administered form.1,3,4 It contains the same medication (DHE) used in hospitals, now in a ready-to-use device.1,5 Brekiya autoinjector does not require refrigeration, assembly, or priming of the device.1 Patients can deliver one dose subcutaneously into the middle of the thigh.1 This may be beneficial for patients who respond inadequately to oral therapies due to lack of efficacy, experience nausea or vomiting during attacks, have gastroparesis, or delay dosing until too late into the attack.1,5,6 “We are thrilled to offer the first and only ready-to-use autoinjector for patients suffering from acute migraine and cluster headaches. Physicians are familiar with DHE, which is an effective and well-established therapy that provides sustained relief for headaches. Our single-dose autoinjector represents an innovative therapeutic option for patients that allows for quick self-administration of the medication during these painful attacks without visiting the emergency room,” said Joe Renda, Senior Vice President, Chief Commercial Officer – Specialty. DHE is commonly administered in emergency rooms, urgent care facilities, and headache clinics intravenously. DHE can be used at any point during a migraine attack, and may protect patients from headache recurrence.1,3,4 Approximately 39 million Americans are living with migraine7, and up to one million with cluster headache.8 Also, headache is the fourth most common reason for emergency department visits, and accounts for 3% of all emergency room visits in the United States.9 There are limited treatment options available for cluster headache, and Brekiya autoinjector represents a new treatment option for this underserved population.2 Do not take Brekiya autoinjector with strong CYP3A4 inhibitors including protease inhibitors and macrolide antibiotics. See additional Important Safety Information below. IndicationBrekiya autoinjector is a prescription medicine used for the acute treatment of migraine with or without aura and acute cluster headaches in adults. Brekiya autoinjector is not used to prevent migraine or used to treat other types of headaches such as hemiplegic migraines (that make you unable to move on one side of your body) or basilar migraines (rare form of migraine with aura). It is not known if Brekiya autoinjector is safe and effective in children. IMPORTANT SAFETY INFORMATIONSerious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Brekiya autoinjector) with strong CYP3A4 inhibitors (such as protease inhibitors and macrolide antibiotics) have been reported rarely. As a result, these medications should not be taken together. Do not use Brekiya autoinjector if you: are taking medicines known as strong CYP3A4 inhibitors, such as: ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, ketoconazole, or itraconazole.have heart problems or a history of heart problems, or uncontrolled high blood pressure.have narrowing of blood vessels in your legs, arms, stomach, or kidneys (peripheral vascular disease).have sepsis, had vascular surgery, severe liver or kidney problems.are allergic to dihydroergotamine, ergot alkaloids, latex, or any of the ingredients in Brekiya autoinjector.have taken any of the following medicines in the last 24 hours: sumatriptan, frovatriptan, ergotamine or ergotamine-type medicines, almotriptan, naratriptan, zolmitriptan, eletriptan, or rizatriptanhave taken any medicines that constrict your blood vessels or raise your blood pressure. Before you take Brekiya autoinjector, tell your healthcare provider about all your medical conditions, including if you: have high blood pressure, liver problems, or kidney problems.have risk factors for heart disease, such as: high blood pressure, high cholesterol levels, smoke, are overweight, diabetes, family history of heart disease.are pregnant or plan to become pregnant. Brekiya autoinjector may cause preterm labor. Brekiya autoinjector should be avoided during pregnancy. Talk to your healthcare provider right away if you are pregnant or want to become pregnant.are breastfeeding or plan to breastfeed. Brekiya autoinjector may reduce breast milk supply and pass into your breast milk. Brekiya autoinjector may be harmful to your baby. Do not breastfeed your baby while taking Brekiya autoinjector and for 3 days after you use Brekiya autoinjector. Talk with your healthcare provider about the best way to feed your baby if you take Brekiya autoinjector. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take: sumatriptan, ergot-type medicine, saquinavir, nefazodone, fluconazole, grapefruit juice, zileuton, nicotine, propranolol or other medicines that can lower your heart rate, any medicines that can increase your blood pressure, selective serotonin reuptake inhibitors. These are not all of the medicines that could affect how Brekiya autoinjector works. Your healthcare provider can tell you if it is safe to take Brekiya autoinjector with other medicines. How should I use Brekiya autoinjector? Certain people should take their first dose of Brekiya autoinjector in their healthcare provider’s office or in another medical setting.Brekiya autoinjector is for injection under the skin (subcutaneous) only.Use Brekiya autoinjector exactly as your healthcare provider tells you to use it.Each autoinjector contains one dose (1 mg).If your headache comes back after the first complete dose, you may give yourself up to 2 more doses as needed. Wait at least one hour between doses.Do not inject more than 3 doses (3 mg) of Brekiya autoinjector in a 24-hour period or 6 doses (6 mg) in a 1-week (7 day) period. What are the possible side effects of Brekiya autoinjector?Brekiya autoinjector can cause serious side effects, including: Heart attack and other heart problems. Heart problems may lead to death. Stop taking Brekiya autoinjector and get emergency medical help right away if you have any symptoms of a heart attack, such as: numbness or tingling in your fingers and toes, muscle pain or cramps in your arms and legs, weakness in your legs, temporary speeding or slowing of your heart rate, or swelling or itching. Brekiya autoinjector is not for people with risk factors for heart disease unless a heart exam is done and shows no problem. Stroke. Stop using Brekiya autoinjector and get emergency medical help right away if you have any of the symptoms of a stroke.Changes in color or sensation in your fingers and toes (Raynaud’s syndrome).Stomach and intestinal problems.Increased blood pressure.Medicine overuse headache. Some people who use too much Brekiya autoinjector may make their headaches worse. If your headaches get worse, your healthcare provider may decide to stop your treatment with Brekiya autoinjector.Preterm labor.Tissue changes (fibrotic complications). Inflammation and fiber-like tissue that is not normal (fibrosis) can occur around the lungs and stomach. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Brekiya autoinjector. Call your healthcare provider for medical advice about side effects. How should I store Brekiya autoinjector? Store at room temperature between 68°F to 77°F (20°C to 25°C). Do not refrigerate or freeze.Protect Brekiya autoinjector from light.Keep Brekiya autoinjector in the original pack until ready to use. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please see full Prescribing Information, including Boxed Warning, Medication Guide, and Instructions for Use at Brekiya.com. *Sustained represents a duration of approximately 24-72 hours2,3†Cluster headache results reported using IV administration.4 References: Brekiya [package insert]. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2025.Data on File. Amneal Pharmaceuticals LLC.Winner P, Ricalde O, Le Force B, Saper J, Margul B. Arch Neurol. 1996;53(2):180-184.Mather PJ, Silberstein SD, Schulman EA, Hopkins MM. Headache. 1991;31(8):525-532.Silberstein SD, Shrewsbury SB, Hoekman J. Headache. 2020;60(1):40-57. doi:10.1111/head.13700Aurora SK, Papapetropoulos S, Kori SH, Kedar A, Abell TL. Cephalalgia. 2013;33(6):408-415.https://migraineresearchfoundation.org/about-migraine/migraine-facts/https://americanmigrainefoundation.org/resource-library/cluster-headache-2/Phelan, M, Thompson NR, Zubair A et al. Emergency department utilization among patients who receive outpatient specialty care for headache: A retrospective cohort study analysis. Headache. 2023;63:472–483. Brekiya is a registered trademark of Amneal Pharmaceuticals LLC. About AmnealAmneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn. Cautionary Statement on Forward-Looking StatementsCertain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. Investor Contact Anthony DiMeoVP, Investor Relations anthony.dimeo@amneal.comMedia ContactBrandon SkopSr. Director, Corporate CommunicationsBrandon.skop@amneal.com PP-PRS-DHE-US-0001 05/2025

Drug Approval

21 Apr 2025

·ir.achievelifesciences.com

Achieve Life Sciences Announces Cytisinicline Phase 3 ORCA-3 Trial Publication on Smoking Cessation in JAMA Internal Medicine

ORCA-3 Demonstrated a Significant Increase in Quitting and Reduction in Nicotine Cravings for Cytisinicline-Treated Participants Compared to Placebo Cytisinicline New Drug Application (NDA) Submission to FDA Planned for June 2025 SEATTLE and VANCOUVER, British Columbia, April 21, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced that complete trial results from its ORCA-3 were published in the Journal of the American Medical Association (JAMA) Internal Medicine. ORCA-3 was the second randomized, placebo-controlled Phase 3 clinical trial evaluating cytisinicline for smoking cessation in 792 U.S. adults. The authors concluded that ORCA-3 reaffirms cytisinicline’s efficacy and tolerability for smoking cessation in adult smokers at both 6- and 12-week treatment durations, including reduction in nicotine cravings and extended cessation benefits through 24 weeks. In addition to previously reported topline results announced in May 2023, the published completed trial results provided further evidence of cytisinicline’s highly targeted effect on treating nicotine dependence by binding to specific nicotine receptors. These consistent results, now published from two large, randomized Phase 3 trials, demonstrated that cytisinicline significantly reduced nicotine cravings and increased the likelihood of quitting smoking. In clinical trials, cytisinicline was well tolerated, which is thought to be due to limited other off-target binding effects that can result in side effects known to be associated with currently available treatments. Similar to the first Phase 3 trial, ORCA-3 participants had an average age of 53 years, smoked a median of 20 cigarettes per day at baseline, and had a median smoking history of 36 years with four prior quit attempts. “Most people who smoke want to quit and it often takes multiple attempts to do so successfully. Our trial participants were no exception and had multiple previous quit attempts, although less than half had previously tried varenicline, possibly due to its well-known adverse event profile,” said Cindy Jacobs, MD, PhD, President and Chief Medical Officer of Achieve Life Sciences. “Cytisinicline is very selective in targeting only nicotine receptors and has shown limited binding to other off-target receptors that can cause side effects, like nausea and gastrointestinal disturbances. We believe this leads to a highly tolerable treatment with cytisinicline, as demonstrated in our clinical trial program.” Results from the ORCA-3 study show that cytisinicline significantly increased the odds of smoking cessation compared to placebo. Cytisinicline also reduced nicotine craving which led to decreased nicotine intake, even among those who continued smoking, as evidenced by both lower craving scores and reduced cotinine levels, a well-known metabolite of nicotine. “More deaths each year in the U.S. are attributed to cigarette smoking than to any other preventable cause, and our current smoking cessation treatment options are limited,” said Nancy Rigotti, MD, Professor of Medicine at Harvard Medical School, Director of Tobacco Research and Treatment Center, Massachusetts General Hospital, and ORCA Program Investigator. “The study findings published today suggest that cytisinicline, if approved by the FDA, could help many smokers to quit and reduce the smoking-related risks to their health.” Achieve plans to submit the cytisinicline New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in June 2025. About ORCA-3 The Phase 3 ORCA-3 trial evaluated 792 adults who smoked cigarettes daily and was conducted at 20 clinical trial locations in the U.S. The trial was initiated in January 2022 and completed enrollment in September 2022, with topline results reported in May 2023. ORCA-3 participants received 3mg cytisinicline dosed 3 times daily for either 6 or 12 weeks and were monitored through 24 weeks post randomization. The trial was blinded, placebo-controlled, and all subjects received behavioral support for the duration of the trial. The primary endpoint was biochemically verified continuous abstinence during the last four weeks of treatment. Secondary outcome measures assessed continued abstinence rates through 6 months from the start of study treatment. The full manuscript is published in Journal of the American Medical Association (JAMA) Internal Medicine. About Achieve Life Sciences, Inc. Achieve Life Sciences is a late-stage specialty pharmaceutical company committed to addressing the global smoking health and nicotine dependence epidemic through the development and commercialization of cytisinicline. The company has successfully completed two Phase 3 studies with cytisinicline for smoking cessation and one Phase 2 study with cytisinicline in vaping cessation. The company has fully enrolled its ongoing open-label safety study with cytisinicline and plans to submit its new drug application for smoking cessation in June 2025. Achieve has also conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication. About Cytisinicline There are approximately 29 million adults who smoke combustible cigarettes.1 Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.2,3 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.3 In addition, there are over 11 million adults in the United States who use e-cigarettes, also known as vaping.4 In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes.5 There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address this critical need. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing and nature of cytisinicline clinical development and regulatory review and approval, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, and the successful commercialization of cytisinicline. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development and commercialization of cytisinicline; the risk that cytisinicline will not receive regulatory approval in a timely manner or at all, or be successfully commercialized; the risk that new developments in the smoking and vaping cessation landscapes require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of macroeconomic and geopolitical conditions, including fluctuating inflation, interest and tariff rates, volatility in the debt and equity markets, actual or perceived instability in the global banking system, global health crises and pandemics and geopolitical conflict and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable. Achieve Contact Nicole Jones ir@achievelifesciences.com 425-686-1510 References 1VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641. 2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017. 3U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014. 4Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483. 5Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924. Released April 21, 2025

Phase 3Clinical ResultPhase 2NDABreakthrough Therapy

17 Apr 2025

·www.prnewswire.com

Prominent Psychiatrist Introduces Breakthrough Treatment for Addiction

NEW YORK, April 17, 2025 /PRNewswire/ -- Dr. DiFrancesco () is deeply enthusiastic about new developments in the treatment of addiction and has launched a new website for individuals who would like to learn more and are seeking treatment. Experience the full interactive Multichannel News Release here: Continue Reading Dr. Eileen DiFrancesco Introduces Breakthrough Treatment For Addiction Dr. Eileen DiFrancesco Introduces Breakthrough Treatment For Addiction Dr. Eileen DiFrancesco a physician in New York City has specialized in Psychiatry and Psychopharmacology for over two decades treating a wide variety of neuropsychiatric disorders, focusing on addiction. She has had the opportunity to train in Ivy League schools and work in the ivory towers of Medicine, but unfortunately, she says there has never been an effective medication for the treatment of addiction - until now. Patients who are taking the popular drug Ozempic, also known as semaglutide which was developed for the treatment of diabetes and weight loss are experiencing remarkable results. Surprisingly, they are not only reporting a decrease in the over consumption of food, but also little or no interest in alcohol. DiFrancesco says this is not a coincidence or a side effect. As published in JAMA, Nature and Science Direct -these medications target neural circuits involved in reward and satiety and therefore greatly curb craving for addictive substances. Semaglutide and a similar medication tirzepatidetide are medication's that mimic a natural hormone called glucagon -like peptide – 1 or GLP -1. These hormones are activated when the GLP one receptor agonist attached to their receptors. What is truly exciting is that GLP one receptors are all over the brain reward pathway. This pathway exists to provide a sense of pleasure or reward when we do something that is essential for our survival or survival of the species such as eating healthy foods having sex and nurturing relationship relationships. The reward or sense of pleasure is intended to make us repeat these behaviors so that our species will survive because we eat well, procreate and take care of others. However, substances and things that are highly pleasurable can take over these reward circuits. This causes the natural rewards to become less pleasurable and even ignored. This is what addictive substances do, they hijack the reward pathway in such a way that they become the focus of an individual's life. According to JAMA, a nationwide register based study with GLP one receptor agonist Semaglutide were associated with a markedly, reduced risk of alcohol use disorders and substance use disorder related hospitalizations. In the journal nature, the administration of GLP one has convincingly shown to reduce alcohol intake and pre-clinical models. Observational studies clearly show that GLP one receptor Agnes are associated with non-volitional reduction and the use of alcohol, nicotine, cocaine and opioids. When GLP one receptor agonist activate the GLP one receptors in the reward pathway, the sense of reward from the addictive substances, including alcohol, nicotine cocaine, and even opioid becomes less rewarding. This serendipitous finding is truly amazing and wonderful. When combined with already existing treatment for addiction, DiFrancesco Psychiatry feels there is finally help and hope for treating this destructive and debilitating disease. If you or someone you love is suffering and would like to learn more, please contact us at: [email protected]. About Dr. Eileen DiFrancesco Dr. Eileen DiFrancesco graduated with honors from the University of Pennsylvania where she received her Bachelor's Degree. After earning a medical degree from Temple University School of Medicine, she received additional training in both Psychiatry and Neurology. Upon completing residency training at Mount Sinai Medical Center in New York City she was appointed Medical Director of the Learning Laboratory, a private facility in Connecticut. There she specialized in diagnosing and treating Attention Deficit Disorder, Addiction, Depression and Bipolar Disorder, using Quantitative EEG also known as Brain Mapping. Her diagnostic skills were also utilized at the Mount Sinai School of Medicine where she assessed psychotic adolescents for Schizophrenia treatment and eligibility for research protocols. SOURCE xsrxdoctor WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 Deals associated with Nicotine

External Link

KEGG	Wiki	ATC	Drug Bank
D03365	Nicotine	N07BA01	DB00184

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Tobacco Use Disorder	Australia	Johnson & Johnson Pacific Pty Ltd.	27 Nov 2001
Nicotine Dependence	United States	Haleon US Capital LLC	13 Jan 1984

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acral Lentiginous Malignant Melanoma	Phase 3	United States	McNeil AB	01 Mar 2011
Smoking Cessation	Phase 3	Czechia	McNeil AB	01 Feb 1999
Dyskinesia, Drug-Induced	Phase 2	United States	Neuraltus Pharmaceuticals, Inc.	01 Oct 2009
Parkinson Disease	Phase 2	United States	Neuraltus Pharmaceuticals, Inc.	01 Oct 2009
Lung Cancer	Phase 1	United States	Pfizer Inc.	16 Jun 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02265874 (CTgov)	Phase 1/2	Sarcoidosis, Pulmonary	50	Habitrol (Treatment)	eiwlxyyqsp(cuhcljkbed) = kwspcbmqpz rixgbnpvpb (xrikjflcof, 0.22) View more	-	24 Apr 2025
				Placebo to Habitrol (Control)	eiwlxyyqsp(cuhcljkbed) = bosqqyclpb rixgbnpvpb (xrikjflcof, 0.04) View more
NCT04994444 (CTgov)	Phase 2/3	Smoking Cessation	49	Nicoderm CQ (Preloading)	dsaxbzwkqi(wydgmagubf) = dssztukcno eashcvcued (ksnbzaswao, 13.2) View more	-	06 Apr 2025
				Nicoderm CQ (Standard Treatment)	dsaxbzwkqi(wydgmagubf) = icvxdmpiks eashcvcued (ksnbzaswao, 21.8) View more
ISC2025	Not Applicable	Cerebral Hemorrhage nicotine exposure	-	Nicotine-exposed group	bhmzsqjcwc(jkiveoeulc) = iwkopkrgws lpiaveoxlo (rfgoybocee )	Positive	30 Jan 2025
				Nicotine (Saline (control) group)	bhmzsqjcwc(jkiveoeulc) = zyaarjanad lpiaveoxlo (rfgoybocee )
ACAAI2024	Not Applicable	Asthma	-	smoking cessation medication (Asthmatic Smokers)	dwvrizqzrp(muhtswxggn) = bulywbktsx nihnhjricd (yzkctwlsku )	-	24 Oct 2024
				smoking cessation medication (Non-asthmatic Smokers)	dwvrizqzrp(muhtswxggn) = aynrvxlmqi nihnhjricd (yzkctwlsku )
NCT04433767 (Pubmed)	Phase 2	Depressive Disorder nicotine metabolite concentrations	29	Transdermal nicotine patches	cvqwnopzmt(awermyxdpb) = improvement in self-reported affective symptoms (apathy, insomnia, rumination, and generalized anxiety symptoms), negativity bias, and disability hejkasoaaq (xfoyvfsinu ) View more	Positive	01 Oct 2024
ESC2024	Not Applicable	Obesity	57	NRT (nicotine patch)	mrrlfdnwve(qjzfunaavm) = ntjpnvlzww bvznfhgwko (muvmhrvohy )	Positive	31 Aug 2024
				NRT + bupropion (NRT+bupr)	mrrlfdnwve(qjzfunaavm) = ubnijujxbp bvznfhgwko (muvmhrvohy )
NCT05253573 (SurvLaos, CTgov)	Phase 2	Smoking Cessation \| Neoplasms	80	Self-help materials (to support smoking cessation)+Nicotine patch (Automated Treatment)	uzizfzubgf = ochdtrgevx yyvnkpkxca (wkdiywfnem, rcujqoyjhu - olrtzytqgk) View more	-	28 Aug 2024
				Self-help materials (to support smoking cessation)+Nicotine patch (Standard Care)	uzizfzubgf = awdizslakm yyvnkpkxca (wkdiywfnem, xkecobmkhn - xeodnfocvc) View more
NCT03612960 (CTgov)	Not Applicable	Acral Lentiginous Malignant Melanoma	34	Very low nicotine content cigarettes (Very Low Nicotine Content Cigarettes)	frsgepiczl(ljsrkhlqto) = nhnconiuqj ompggflogf (pwpfubhxet, 0.18) View more	-	20 Aug 2024
				Normal nicotine content cigarettes (Normal Nicotine Content Cigarettes)	frsgepiczl(ljsrkhlqto) = apliffbfjy ompggflogf (pwpfubhxet, 0.18) View more
NCT03272685 (CTgov)	Phase 3	Nicotine Dependence	799	Very Low Nicotine Content Cigarettes (Very Low Nicotine Content Cigarettes)	hrgosadmia(imprpwfmwn) = yelykehuhx etgiqoixaj (egnbsvoacz, 7.88) View more	-	20 Aug 2024
				Normal Nicotine Content Cigarettes (Normal Nicotine Content Cigarettes)	hrgosadmia(imprpwfmwn) = ztnvqulohm etgiqoixaj (egnbsvoacz, 9.07) View more
NCT03634839 (CTgov)	Phase 1	Tobacco Use Disorder	42	Flavoring Agents+Nicotine (Sweet Non-menthol, Nicotine 36mg/ml)	dlkasvfduc(tcxhsmlgne) = opjeoijvmg tnyvrzmpab (ktsxzzwhpn, 3.158) View more	-	09 Aug 2024
				Flavoring Agents+Nicotine (Sweet Menthol, Nicotine 36mg/ml)	dlkasvfduc(tcxhsmlgne) = fzodrefnqp tnyvrzmpab (ktsxzzwhpn, 3.158) View more

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