[Translation] A single-center, randomized, open-label, single-dose, two-sequence, two-period, double-crossover, fasting and fed bioequivalence study of naproxen sodium tablets (275 mg) in healthy subjects

主要研究目的：以Atnahs Pharma Netherlands B.V.持证的萘普生钠片（商品名：Apranax®，规格：275 mg）为参比制剂，以长春海悦药业股份有限公司生产的萘普生钠片（规格：0.275 g（相当于萘普生250 mg））为受试制剂，通过单中心、随机、开放、单次给药、两制剂、两序列、两周期、双交叉的临床研究来评价两种制剂在空腹和餐后条件下的人体生物等效性。次要研究目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

The main purpose of the study is to use the naproxen sodium tablets (trade name: Apranax®, specification: 275 mg) certified by Atnahs Pharma Netherlands B.V. as the reference preparation and the naproxen sodium tablets (specification: 0.275 g (equivalent to naproxen 250 mg)) produced by Changchun Haiyue Pharmaceutical Co., Ltd. as the test preparation to evaluate the bioequivalence of the two preparations under fasting and postprandial conditions through a single-center, randomized, open, single-dose, two-preparation, two-sequence, two-period, double-crossover clinical study. Secondary purpose of the study: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date28 Oct 2024

Sponsor / Collaborator

Changchun Haiyue Pharmaceutical Co., Ltd

NCT05900336

/ RecruitingPhase 4IIT

Non-Steroidal Anti-Inflammatory Drug (NSAID) Response and Central Sensitization of Pain in Women With Dysmenorrhea

Menstrual pain is the most common gynecological complaint and the leading cause of school and work absences in reproductive-age girls and women. One of the primary treatments for menstrual pain is use of nonsteroidal anti-inflammatory drugs (NSAIDs; over-the-counter medications such as naproxen, ibuprofen, or aspirin), although up to 18% of women do not get pain relief from these medications. One reason for this may be due to central sensitization of pain, which is when alterations in the central nervous system change how pain is processed in the brain and experienced. Determining the role of central sensitization in menstrual pain is important because central sensitization is associated with the development of chronic pain. Understanding the relationship between NSAID response and central sensitization is important because it could indicate women who may go on to develop chronic pain later in life. This study would directly address this question. Identifying women at risk for chronic pain would help target new treatments to this vulnerable group to ideally prevent pain from becoming chronic. This is particularly important for women in the military because the severity of menstrual pain is associated with missed work, such that in active-duty military women, less than 4.4% with mild menstrual pain missed work, whereas 20.7% of women with moderate to severe menstrual pain missed work. Addressing the significant impact of menstrual pain for military women will help reducing suffering and potentially decrease the risk of developing future chronic pain problems in this population.

Start Date25 Mar 2024

Sponsor / Collaborator

McLean Hospital, Inc.

[+2]

CTR20240211

/ CompletedNot Applicable

随机、开放、两制剂、两序列、两周期、自身交叉对照设计，评价中国健康受试者在空腹及餐后状态下单次口服萘普生钠片后的生物等效性正式试验

[Translation] A randomized, open-label, two-dose, two-sequence, two-period, self-crossover controlled study to evaluate the bioequivalence of naproxen sodium tablets in Chinese healthy subjects after a single oral dose in the fasting and fed state

以呋欧医药科技（湖州）有限公司提供的萘普生钠片为受试制剂；并以Atnahs Pharma Netherlands B.V.的萘普生钠片为参比制剂，进行人体相对生物利用度和生物等效性评价。

[Translation]

Naproxen Sodium Tablets provided by Fuou Pharmaceutical Technology (Huzhou) Co., Ltd. were used as the test preparation, and Naproxen Sodium Tablets from Atnahs Pharma Netherlands B.V. were used as the reference preparation to evaluate the relative bioavailability and bioequivalence in humans.

Start Date20 Feb 2024

Sponsor / Collaborator

Furou Pharmaceutical Technology (Huzhou) Co., Ltd.

100 Clinical Results associated with Naproxen Sodium

100 Translational Medicine associated with Naproxen Sodium

100 Patents (Medical) associated with Naproxen Sodium

1,110

Literatures (Medical) associated with Naproxen Sodium

01 Aug 2025·TALANTA

Skin-interfaced sweat monitoring patch constructed by flexible microfluidic capillary pump and Cu-MOF sensitized electrochemical sensor

Article

Author: Shi, Huanhuan ; Cao, Yu ; Zhao, Rui ; Zheng, Yun ; Wu, Hongwen ; Jia, Xuanhao ; Tan, Zhongjian ; Xu, Weizheng

The limitations of skin-interfaced sweat monitoring are mainly reflected in the effective collection of sweat and the high sensitivity of the detection. This work proposes a new type of sweat monitoring patch based on a flexible microfluidic chip fabricated by a capillary pump and a copper-based metal-based organic framework (Cu-MOF) sensitized electrochemical sensor. The sweat in the microchannel is driven by a capillary pump to ensure the smooth collection and transportation. The sweat collection channel adopts the ingenious design of wedge-shaped structure, which helps to spontaneously generate Laplacian forces to direct sweat to the detection area. The detection area combines upper and lower capillary pumps, which aim to improve the efficiency of sweat collection. The controllable preparation of Cu-MOF was realized by using a micro-mixer, and the glucose sensor was prepared with it as the probe. The Cu-MOF/PANI layered electrode was prepared, which effectively improved the sensitivity of glucose detection and achieved a significant detection limit of 2.84 μM in the concentration range of 0-1 mM. Sodium and potassium selective electrode were also integrated into a unified screen-printed electrode, and a portable electrochemical detection module, a Bluetooth transmission module, and a mobile phone receiving application were developed. The sweat monitoring patch shows potential in applications such as sports performance monitoring, healthcare, and personalized medicine, opening new avenues for non-invasive health monitoring and early disease detection.

01 Apr 2025·Journal of Cachexia Sarcopenia and Muscle

Ibuprofen, Flurbiprofen or Naproxen Sodium Minimally Influences Musculoskeletal Adaptations to Treadmill Exercise in Rats

Article

Author: Hughes, Julie M. ; Staab, Jeffery S. ; Leiss, Maximus C. ; Varanoske, Alyssa N. ; Reynoso, Marinaliz ; Roberts, Brandon M. ; Kelley, Alyssa M. ; Kolb, Alexander L. ; Naimo, Marshall A. ; Geddis, Alyssa V. ; Tomlinson, Ryan E. ; Ciuciu, Alexandra ; Mehta, Nikhil

ABSTRACT:

Background:

Non‐steroidal anti‐inflammatory drugs (NSAIDs) may influence musculoskeletal health. The purpose of this study was to compare the effects of three different NSAIDS: naproxen sodium, ibuprofen, flurbiprofen or a placebo on musculoskeletal adaptations in rodents with or without 6 weeks of aerobic exercise.

Methods:

Nine‐week‐old male Wistar rats (n = 80) were randomized to either exercise (EX) or no‐exercise control (CON) conditions and treated with naproxen, ibuprofen (IBU), flurbiprofen (FLU) or placebo (PLA). For exercise, rats ran 5 days per week for 6 weeks at a 5% incline on a motorized treadmill for 30 min. Three‐point bending (3 PB) and microcomputed tomography (microCT) were measured in the femur. Anabolic muscle signalling pathways were measured in the quadriceps. Muscle fibre cross‐sectional area (CSA) and fibre type were measured in the soleus. Data were analysed using a two‐way ANOVA for treatment by condition and is visualized as mean ± standard deviation.

Results:

For 3 PB, there was an exercise effect for ultimate bending energy, postyield energy, toughness, postyield toughness, postyield displacement, ultimate strain and postyield strain (all, p < 0.05). There was a treatment by condition effect for Young's Modulus, where placebo exercise was less than placebo control (PLA EX: 3256.44 ± 463.41 MPa, PLA CON: 4849.94 ± 836.70 MPa, p < 0.05). For microCT, there was a treatment by condition effect for trabecular thickness (p = 0.047) and the IBU EX group increased thickness compared with the IBU CON group (IBU EX: 0.133 ± 0.011 mm, IBU CON: 0.121 ± 0.007 mm, p = 0.027). In the quadriceps, for myosin heavy chain abundance, there was a treatment by condition effect (p = 0.046) and ibuprofen exercise was lower than ibuprofen control (IBU EX: 0.636 ± 0.513 AU, IBU CON: 1.81 ± 1.012 AU, p = 0.016). There was no treatment by condition effect for phosphorylation of the AKT, AMPK or ERK pathways (all, p > 0.05). In the soleus, there was no treatment by condition effect for fibre type percentage or muscle CSA (p > 0.05).

Conclusions:

NSAIDs did not have a strong negative or positive effect on musculoskeletal adaptations to 6 weeks of treadmill running in young healthy male rodents.

07 Mar 2025·JOURNAL OF ORGANIC CHEMISTRY

Synthesis and Performance of l-Tryptophanamide and (S)-1-(Naphthalen-2′-yl)ethanamine-Based Marfey-Type Derivatives for Amino Acid Configurational Analysis: Diastereomeric Resolutions Directed by π–Cation Bonding

Article

Author: Salib, Mariam N. ; Molinski, Tadeusz F.

The configurational analysis of amino acids (AAs) in natural product peptides, often containing nonproteinogenic AAs, is mostly carried out by the venerable Marfey's method using a chiral derivatizing agent (CDA) 1-fluoro-2,4-dinitrophenyl-5-l-alaninamide (l-FDAA)─Marfey's reagent─which undergoes S_NAr reaction of the 1° amino group. The resulting AA-DAA derivatives are mostly well-separated by reversed-phase HPLC, but some DAA derivatives resist resolution. Here, we report the synthesis and characterization of two CDAs: l-FDTA (4) in which the l-alanine-derived auxiliary is replaced by l-tryptophanamide and (S)-FDNE (3) where the auxiliary is S-(6-methoxynaphth-2-yl)-1-ethylamine. Side-by-side comparisons of the two reagents were carried out by AA derivatization and reversed-phase HPLC analysis with variables such as organic solvent, additives, and the ionic strength of the mobile phase. l-DTA derivatives of l- and d-AAs were found to show superior HPLC performance and an improvement in resolutions. When incorporated into the mobile phase, the ammonium ion (NH₄⁺, 0-100 mM) showed a dramatic influence on differential retention times [Δt_R = Δt_Rd - Δt_Rl] of several key AAs. We attributed the effect to π-cation interactions between the indole ring of DTA and the NH₄⁺ counterion in the analyte, a hypothesis supported by ¹H NMR titrations and DFT calculations.

News (Medical) associated with Naproxen Sodium

11 Mar 2025

·www.prnewswire.com

Currax Pharmaceuticals: Peer-Reviewed Study in Obesity Pillars Further Substantiates Cardiovascular Safety Profile of CONTRAVE®/MYSIMBA®

BRENTWOOD, Tenn., March 11, 2025 /PRNewswire/ -- Currax Pharmaceuticals LLC ("Currax"), a specialty pharmaceutical company and manufacturer of the #1 branded oral weight loss medication CONTRAVE® (naltrexone HCl/bupropion HCl), today announced the publication of its Cardiovascular Health Outcomes Analysis (HOA) for CONTRAVE®/MYSIMBA® in Obesity Pillars, the official journal of the Obesity Medicine Association. This peer-reviewed study, based on electronic health record data from more than 24,600 patients followed for over 4.7 years, found no evidence of excess cardiovascular risk and no statistically significant difference in major adverse cardiovascular events (MACE) between CONTRAVE/MYSIMBA and the comparator drug. The study's publication provides important real-world evidence that further substantiates the cardiovascular safety profile of CONTRAVE/MYSIMBA building on findings from prior clinical trials, a systemic literature review, two published FDA Adverse Event Reporting System (FAERS) database studies, and over ten years of post-marketing safety surveillance. These results provide valuable insights to support regulatory and clinical decision-making in the treatment of obesity. "The publication of this analysis in Obesity Pillars underscores the utility of evaluating long-term cardiovascular outcomes in routine clinical practice," said Michael Kyle, M.D., SVP, Chief Medical Officer of Currax Pharmaceuticals. "The findings further substantiate the cardiovascular safety profile of CONTRAVE/MYSIMBA, aligning with previous clinical and observational studies." CONTRAVE, approved in the U.S. and marketed in Europe as MYSIMBA, has been studied extensively in both randomized clinical trials and observational settings. The latest analysis builds upon prior research, including the LIGHT trial, and complements the ongoing INFORMUS trial, a large-scale cardiovascular outcomes study, which now has enrolled more than 3,000 patients and is designed to meet regulatory post-marketing requirements to further characterize long-term cardiovascular safety. "Obesity is a serious chronic disease, and it's critical that healthcare professionals have access to rigorous, data-driven evidence when considering treatment options," said George Hampton, President and CEO of Currax Pharmaceuticals. "Currax continues to invest in clinical trials designed to increase the utility of Contrave for physicians treating obesity." The full study is available in Obesity Pillars: About Currax Pharmaceuticals LLC Currax Pharmaceuticals LLC is a specialty pharmaceutical business focused on tackling the #1 and #2 causes of preventable death in the United States, smoking and obesity. Currax distributes a range of both branded and generic pharmaceutical products, including CONTRAVE® (naltrexone HCl/bupropion HCl), ONZETRA® Xsail® (sumatriptan nasal powder), Silenor® (doxepin), Treximet®, (sumatriptan/naproxen sodium), and the authorized generic of Treximet®. For more information, please visit . WHAT IS CONTRAVE? Along with diet and exercise, CONTRAVE is a prescription weight-loss medicine that may help some adults with a BMI > 30 kg/m2 (obese) or with a BMI of > 27 kg/m2 (overweight) with at least one weight-related medical problem such as high blood pressure, high cholesterol, or type 2 diabetes, lose weight and keep the weight off. It is not known if CONTRAVE changes your risk of heart problems or stroke or of death due to heart problems or stroke. It is not known if CONTRAVE is safe and effective when taken with other prescription, over-the-counter, or herbal weight-loss products. CONTRAVE is not approved to treat depression or other mental illnesses, or to help people quit smoking (smoking cessation). IMPORTANT SAFETY INFORMATION CONTRAVE can cause serious side effects including: Suicidal thoughts or actions: One of the ingredients in CONTRAVE is bupropion. Bupropion has caused some people to have suicidal thoughts or actions or unusual changes in behavior, whether or not they are taking medicines used to treat depression. Bupropion may increase the risk of suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. If you already have depression or other mental illnesses, taking bupropion may cause it to get worse, especially within the first few months of treatment. While taking CONTRAVE, you or your family members should pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when you start taking CONTRAVE or when your dose changes. Stop taking CONTRAVE and call a healthcare provider right away if you or your family members notice any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; depression; anxiety; feeling agitated or restless; panic attacks; irritability; aggression, anger, or violence; acting on dangerous impulses; an extreme increase in activity and talking; other unusual changes in behavior or mood; trouble sleeping. CONTRAVE is not approved for use in children under the age of 18. Do not take CONTRAVE if you have uncontrolled high blood pressure; have or have had seizures; use other medicines that contain bupropion such as WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, APLENZIN and ZYBAN; have or have had an eating disorder called anorexia or bulimia; are dependent on opioid pain medicines or use medicines to help stop taking opioids, or are in opiate withdrawal; drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines and stop using them all of a sudden; are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs) in the past 14 days; or are allergic to any of the ingredients in CONTRAVE. Tell your healthcare provider about all of your medical conditions including if you have: depression or other mental illnesses; attempted suicide; seizures; head injury; tumor or infection of brain or spine; low blood sugar or low sodium; liver or kidney problems; high blood pressure; heart attack, heart problems, or stroke; eating disorder; drinking a lot of alcohol; prescription medicine or street drug abuse; are 65 or older; diabetes; pregnant or planning to become pregnant; or breastfeeding. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. CONTRAVE may cause serious side effects, including: Seizures. There is a risk of having a seizure when you take CONTRAVE. The risk of seizure is higher in people who take higher doses of CONTRAVE, have certain medical conditions, or take CONTRAVE with certain other medicines. Do not take any other medicines while you are taking CONTRAVE unless your healthcare provider has said it is okay to take them. If you have a seizure while taking CONTRAVE, stop taking CONTRAVE and call your healthcare provider right away. Risk of opioid overdose. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of naltrexone. This can lead to serious injury, coma, or death. Get emergency medical help right away if you take opioids and you: have trouble breathing become very drowsy with slowed breathing have slow, shallow breathing feel faint, very dizzy, confused, or have unusual symptoms Sudden opioid withdrawal. People who take CONTRAVE must not use any type of opioid including street drugs, prescription pain medicines, cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, for at least 7 to 10 days before starting CONTRAVE. Using opioids in the 7 to 10 days before you start taking CONTRAVE may cause you to suddenly have symptoms of opioid withdrawal when you take it. Sudden opioid withdrawal can be severe, and you may need to go to the hospital. Tell your healthcare provider you are taking CONTRAVE before a medical procedure or surgery. Severe allergic reactions. Stop taking CONTRAVE and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of an allergic reaction: rash, itching, hives, fever, swollen lymph glands, painful sores in your mouth or around your eyes, swelling of your lips or tongue, chest pain, or trouble breathing. Increases in blood pressure or heart rate. Some people may get high blood pressure or have a higher heart rate when taking CONTRAVE. Your healthcare provider should check your blood pressure and heart rate before you start taking, and while you take CONTRAVE. Liver damage or hepatitis. Stop taking CONTRAVE and tell your healthcare provider if you have any of the following symptoms of liver problems: stomach area pain lasting more than a few days, dark urine, yellowing of the whites of your eyes, or tiredness. Your healthcare provider may need to stop treating you with CONTRAVE if you get signs or symptoms of a serious liver problem. Manic episodes. Bupropion can cause some people who were manic or depressed in the past to become manic or depressed again. Visual problems (angle-closure glaucoma). Signs and symptoms may include: eye pain, changes in vision, swelling or redness in or around the eye. Talk with your healthcare provider to find out if you are at risk for angle-closure glaucoma and to get treatment to prevent it if you are at risk. Increased risk of low blood sugar in people with type 2 diabetes mellitus who also take medicines to treat their diabetes (such as insulin or sulfonylureas). You should check your blood sugar before you start taking CONTRAVE and while you take CONTRAVE. The most common side effects of CONTRAVE include nausea, constipation, headache, vomiting, dizziness, trouble sleeping, dry mouth, and diarrhea. These are not all of the possible side effects of CONTRAVE. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please see the Full Prescribing Information, including Medication Guide, for CONTRAVE. Media Contact [email protected] SOURCE Currax Pharmaceuticals LLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalClinical Result

17 Aug 2023

·www.fiercepharma.com

Bayer pledges $500K in drugs and cash relief to Maui following devastating wildfires

The fire in Lahaina, Hawaii, is now the deadliest in more than a century. In the aftermath of devastating wildfires on Maui, Bayer is standing up as one of the first pharmaceutical companies to offer relief. The German conglomerate is providing a cash donation of $250,000 to the island, plus a donation of essential healthcare products also worth $250,000. Bayer has operated in Maui for more than half a century, the company said in a Wednesday release. The company said it “stands in solidarity with those impacted and offers heartfelt condolences for the losses endured.” The fire in Lahaina, Hawaii, is now the deadliest in more than a century, according to the U.S. Fire Administration and CNN. To date, some 2,200 structures have been destroyed or damaged, 86% of which are residential, the state’s governor, Josh Green, has said. The death toll was 110 as of Wednesday. Of Bayer’s cash donation, $150,000 will go to the Hawaii Community Foundation’s Maui Strong program, which is helping coordinate resources for recovery efforts. Another $50,000 is going to the Maui Food Bank, while Bayer also plans to provide $50,000 in the future as needs emerge. Its donation of medical supplies will go to Direct Relief, which is working in conjunction with Hawaiian healthcare partners to deliver immediate medical aid to those in need. Bayer’s donation comprises items such as Aspirin, Aleve, Claritin, plus an unnamed antibiotic. Bayer notes that its employees in Hawaii on Maui, Molokai and Oahu have also donated more than 3,000 pounds of essential supplies, including food, water and more. The pharma giant is also matching employee contributions through its Bayer Fund program. Pharmaceutical companies have repeatedly stepped up in recent years amid a spate of natural disasters and manmade conflicts. Earlier this year, following a devastating earthquake on the border of Turkey and Syria, drugmakers near and far chipped in with cash donations and essential medicine pledges. And in 2022, scores of drugmakers rallied around Ukraine following the country’s invasion by Russia. Those efforts saw companies like Roche donate 150,00 packages of the antibiotic Rocephin to Ukraine, while others, such as Sanofi, put up sums in the millions of euros. Editor's note: Is your company doing something to help with relief efforts in Hawaii? Email Fraiser Kansteiner at fkansteiner@questex.com to have your company's efforts reflected in this story.

15 Aug 2023

·www.biospace.com

Searchlight Pharma Announces Suvexx® Launch in Europe, along with Deal Expansion to all E.U. Markets

EUR600K upfront payment upon signing the new amendment agreement EUR400K payment once launched in significant E.U. markets Deal also includes sales-based milestone payments, royalties and revenue pursuant to the supply agreement New amendment expands the agreement to all E.U. territories MONTREAL--(BUSINESS WIRE)-- Searchlight Pharma Inc. (“Searchlight” or the “Company”), a private Canadian specialty pharmaceutical company today announced that Orion Corporation (“Orion”) has launched Suvexx® in select countries covered in the 2020 exclusive license and supply agreement (the “License Agreement”) between Nuvo Pharmaceuticals (Ireland) DAC (“Nuvo Ireland”) and Orion, with the product launches continuing into 2024. Orion is headquartered in Espoo, Finland with its products marketed in over one hundred countries worldwide. In FY2022, Orion generated over EUR1.34 billion in net sales. Orion maintains its own commercial infrastructure in most key European markets with a focus on neurology, oncology, respiratory, pain and women’s health. Orion is a public company trading on the Nasdaq Helsinki exchange under the HEL:ORNBV and HEL:ORNAV ticker symbols. In December 2020, Searchlight’s wholly owned subsidiary, Nuvo Ireland entered into the License Agreement with Orion for the exclusive right to package, distribute, market and sell Suvexx in Finland, Sweden, Denmark, Norway, Poland, Hungary, Latvia, Lithuania and Estonia (the “Territory”). Under the terms of that agreement, Orion is responsible for obtaining and maintaining the marketing authorizations for Suvexx in the Territory and for managing all Territory specific commercial activities. The relevant acute migraine prescription treatment market in Europe was valued at over EUR220 million in the past 12 months based on Company estimates. Nuvo Ireland and Orion have also entered into an amendment to the original License Agreement for the exclusive right to package, distribute, market and sell Suvexx in all remaining E.U. countries outside of the original License Agreement Territory. Orion anticipates filing the marketing authorization application immediately and expects to commercially launch Suvexx in Austria, Belgium, the Czech Republic, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Slovakia, Spain, Switzerland and the U.K. during 2024, subject to receipt of marketing authorization and pricing approval. The signing of the amendment triggered an upfront payment of EUR600K by Orion to Nuvo Ireland. Under the terms of the amendment, Nuvo Ireland will be entitled to future sales-based milestone payments, royalties and revenues pursuant to the supply agreement between the parties. "The launch of Suvexx in Europe is another important milestone for Searchlight and a further indication of the value arising out of the acquisition of Miravo Healthcare earlier this year,” said Mark Nawacki, Searchlight’s President and Chief Executive Officer. “A key component of our growth strategy is to create options for the diversification of our business beyond its Canadian market search, acquisition and commercialization roots. In this vein, we are pleased to expand our Suvexx agreement to encompass the entirety of the E.U. market, and to work with Orion, a partner with proven therapeutic area expertise and an established commercial infrastructure, as a license and distribution partner across the E.U." About Suvexx Suvexx is a patent protected, fixed dose combination of naproxen sodium and sumatriptan that was originally developed by the Aralez Pharmaceuticals Inc. wholly owned subsidiary POZEN, Inc. (POZEN) in collaboration with Glaxo Group Limited, d/b/a GSK (GSK). The product is formulated with POZEN's patented technology (now owned by Searchlight) of combining a triptan, sumatriptan 85 mg, with an NSAID, naproxen sodium 500 mg and GSK's RT Technology in a single tablet. In 2008, the U.S. Food and Drug Administration (FDA) approved Treximet (the U.S. brand name for Suvexx) for the acute treatment of migraine attacks, with or without aura, in adults. Treximet is currently commercialized in the U.S. by Currax Holdings USA LLC. Searchlight owns the product and intellectual property rights to Suvexx in Canada and its wholly owned subsidiary Nuvo Ireland owns the intellectual property rights to Suvexx outside of Canada. About Orion Corporation Orion is a globally operating Finnish pharmaceutical company – a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and self-care products. The core therapy areas of its pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. Orion's net sales in 2022 amounted to EUR1.34 billion and the company had about 3,500 employees at the end of the year. Orion's A and B shares are listed on Nasdaq Helsinki. About Searchlight Pharma Searchlight Pharma Inc., headquartered in Montreal, is a leading Canadian-based specialty healthcare company that executes best-in-class search, acquisition, commercialization, and focused development of innovative and unique specialty healthcare products. Following its acquisition of Miravo Healthcare in March 2023, Searchlight’s core promoted products now focus on women’s health, dermatology, allergy, pain management and hospital specialty markets, and its team is committed to improving people’s lives by bringing the right products to market. Follow Searchlight, learn more about what it does, and get to know its product portfolio at View source version on businesswire.com: Contacts FOR MORE INFORMATION, PLEASE CONTACT: Mark Nawacki President & CEO info@searchlightpharma.com Source: Searchlight Pharma Inc. View this news release online at:

License out/inDrug ApprovalAcquisition

100 Deals associated with Naproxen Sodium

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KEGG	Wiki	ATC	Drug Bank
D00970	-	-	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute migraine	Australia	Atnahs Pharma Australia Pty Ltd.	03 Nov 1998
Ankylosing Spondylitis	United States	Atnahs Pharma US Ltd.	04 Sep 1980
Bursitis	United States	Atnahs Pharma US Ltd.	04 Sep 1980
Gout	United States	Atnahs Pharma US Ltd.	04 Sep 1980
Juvenile Idiopathic Arthritis	United States	Atnahs Pharma US Ltd.	04 Sep 1980
Osteoarthritis	United States	Atnahs Pharma US Ltd.	04 Sep 1980
Pain	United States	Atnahs Pharma US Ltd.	04 Sep 1980
Primary dysmenorrhea	United States	Atnahs Pharma US Ltd.	04 Sep 1980
Rheumatoid Arthritis	United States	Atnahs Pharma US Ltd.	04 Sep 1980
Tendinopathy	United States	Atnahs Pharma US Ltd.	04 Sep 1980

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Pain, Postoperative	Phase 3	United States	Bayer AG	01 Oct 2010
Toothache	Phase 3	United States	Bayer AG	01 Jun 2008
Osteoarthritis, Knee	Phase 2	United States	Bayer AG	29 Jun 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03879408 (CTgov)	Phase 2	Toothache	290	placebo (Arm 1: Placebo)	kwucvkddem(lcutlhjuxi) = qmqmasoeid dmkompwgal (bskaiywmsm, 2.181) View more	-	05 Dec 2022
				Naproxen (Arm 2: Naproxen Sodium 440 mg)	kwucvkddem(lcutlhjuxi) = lrjsaagfrg dmkompwgal (bskaiywmsm, 1.562) View more
NCT04307940 (CTgov)	Phase 4	Toothache	221	Naproxen Sodium (Aleve, BAY117031) (Naproxen Sodium)	vjwflueasc(vtbqqomdkv) = gghnoozjqc eoykqfhgom (eupalpuakk, 3.09) View more	-	07 Oct 2021
				Placebo (Placebo)	vjwflueasc(vtbqqomdkv) = hkwiktyoag eoykqfhgom (eupalpuakk, 4.35) View more
NCT04066426 (CTgov)	Phase 4	Soft tissue rheumatism \| Myofascial Pain Syndromes	200	naproxen sodium+paracetamol+dexamethasone+codeine phosphate (Naproxen Sodium+Codeine Phosphate)	mlxmsnkyeu(mpamurmtww) = vqbkqkihxl iduvvmemyo (jqhkhnzoov, 1.86) View more	-	15 Feb 2021
				naproxen sodium+paracetamol+dexamethasone+codeine phosphate (Naproxen Sodium+Dexamethasone)	mlxmsnkyeu(mpamurmtww) = equwadugup iduvvmemyo (jqhkhnzoov, 1.76) View more
NCT03566979 (CTgov)	Phase 3	Toothache \| Pain, Postoperative	501	Placebo (Placebo)	olcbqrzfzn(yeopndtxvq) = pwbcbwzfmp pnjukwkttw (tudsmielig, hdrffafzvj - nhdqlhzbgh) View more	-	09 Apr 2020
				Naproxen Sodium (Test Naproxen Sodium Tablet (440 mg))	olcbqrzfzn(yeopndtxvq) = zoacazwhdw pnjukwkttw (tudsmielig, mnqqpajxcz - umjzkresnq) View more
NCT03404206 (CTgov)	Phase 4	Toothache \| Pain, Postoperative	387	Naproxen Sodium (Aleve, BAY117031) (Naproxen Sodium (Aleve, BAY117031))	symhlvjrwl = skvduexmzd mvadhdomzf (wdjzadhdcf, qhqxyysccg - hvewizohjb) View more	-	18 Jul 2019
				Ibuprofen (Advil) (Ibuprofen (Advil))	symhlvjrwl = swwbvoniyu mvadhdomzf (wdjzadhdcf, ksflnfjlsi - yhwftysxyb) View more
NCT02388191 (CTgov)	Not Applicable	Pain \| Contraception	119	Naproxen sodium (Naproxen Sodium)	ptlzzkpjuu(awfrxevfiq) = eldiukocos dtpibvbszi (imhfpdpqrp, xpdouzavvp - vwtxpboswk) View more	-	22 Jun 2017
				Placebo tablet (Placebo)	ptlzzkpjuu(awfrxevfiq) = dxfbvziovr dtpibvbszi (imhfpdpqrp, qohhkajcuv - yjcaegjkda) View more
NCT02388191 (Pubmed \| Obstet Gynecol)	Not Applicable	Pain	118	Naproxen sodium	fkidldjcrd(tgnqwrrivm) = dfswwxbyba medszgduvx (qrroiycihj ) View more	-	01 Dec 2016
				Placebo	fkidldjcrd(tgnqwrrivm) = jywxkcjyoz medszgduvx (qrroiycihj ) View more
NCT01165307 (iTOM, CTgov)	Phase 4	Menorrhagia	77	Naproxen sodium pills+Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills (Medical Therapy)	lzfybywixz(zovddpjcgl) = phxpthxifj hbyulnitao (mrmkftkpch, cqkhooletj - ixymdmzykd) View more	-	15 Nov 2016
				NovaSure® Radiofrequency Endometrial Ablation (Radiofrequency Endometrial Ablation)	lzfybywixz(zovddpjcgl) = aoyrczlwiz hbyulnitao (mrmkftkpch, yjzlkfbjtq - mgohmqdequ) View more

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