Multiple-dose, open-label, laboratory blinded, randomized, 2-period, 2-sequence, crossover, steady-state bioequivalence study comparing the Test Product Naproxen sodium 660 mg modified release tablets with the Reference Product Actromadol 660 mg Modified-Release tablets in healthy adult male and female subjects under fed conditions.

Start Date11 May 2026

Sponsor / Collaborator-

CTIS2025-521732-11-00

/ CompletedPhase 1

Single dose, open-label, laboratory blinded, randomized, 2-treatment, 2-period, 2-sequence, crossover, pivotal study to assess the relative bioavailability of Test Product Naproxen sodium 660 mg modified release tablets to Reference Product Actromadol 660 mg Modified-Release tablets in healthy adult male and female subjects under fed conditions.

Start Date09 Mar 2026

Sponsor / Collaborator-

CTIS2025-524035-39-00

/ Not yet recruitingPhase 1

Start Date14 Jan 2026

Sponsor / Collaborator-

100 Clinical Results associated with Naproxen Sodium

100 Translational Medicine associated with Naproxen Sodium

100 Patents (Medical) associated with Naproxen Sodium

709

Literatures (Medical) associated with Naproxen Sodium

01 Jun 2026·ARCHIVES OF MEDICAL RESEARCH

Introducing an In Vivo Protocol to Evaluate Skin Penetration of Topical Drugs: Proof-of-Concept with Naproxen in Humans

Article

Author: González-Flores, María de Lourdes ; Jiménez-Andrade, Juan Miguel ; Cabrera-Fuentes, Hector A ; Ruiz-Ruiz, Mariannela C ; Vázquez-Román, Ruth ; Castañeda-Hernández, Gilberto

BACKGROUND:

Current clinical guidelines recommend the use of topical nonsteroidal anti-inflammatory drugs (NSAIDs), such as naproxen, to treat hand and knee osteoarthritis and other musculoskeletal disorders. However, detailed insights into naproxen's cutaneous pharmacokinetics remain underexplored.

AIM:

This study aims to provide quantitative in vivo evidence that naproxen skin penetration follows Fick's law of diffusion. In addition, it seeks to explore whether the penetration profile is compatible with localized presystemic retention, which could improve therapeutic efficacy and limit systemic exposure.

METHODS:

Five healthy volunteers participated in this proof-of-concept study. A commercially available 5.5% naproxen sodium gel was applied to the volar surface of the forearm, and naproxen penetration kinetics were determined. The naproxen penetration versus time profiles were fitted to a mathematical model assuming Fick's law of diffusion, and the model's predictive performance was evaluated.

RESULTS:

Naproxen skin penetration increased during the first 4 h reaching a plateau that indicated equilibrium was achieved and a presystemic drug reservoir was formed, limiting systemic exposure. The experimental data were adequately fitted by a mathematical model based on Fick's law of diffusion. Maximal naproxen release (M_∞), expressed as a percentage of the actually applied dose, was 23.85 ± 1.81%. The penetration rate constant (k) was 0.73 ± 0.18 h^-1, and the penetration half-life (t_1/2) was 0.99 ± 0.21 h.

CONCLUSION:

This study demonstrates that topical naproxen follows predictable Fickian kinetics and shows a potential tissue-level reservoir after penetration. This supports its use as a safe and effective topical agent for localized inflammatory conditions.

01 May 2026·HEADACHE

Novel optimization of multi‐mechanistic approaches for the acute treatment of a migraine attack: A review

Review

Author: Alan M. Rapoport MD ; Stephen Silberstein MD

Abstract:

Objective:

To highlight key factors required to optimize multi‐mechanistic approaches with oral combination treatments for the acute management of a migraine attack.

Background:

Given the complex multi‐factorial nature of migraine, combining treatments with different mechanisms of action should improve outcomes compared to monotherapies, but this has not been demonstrated with all treatment combinations.

Methods:

For this narrative review, we searched PubMed using combinations of these terms: migraine, acute treatment, combination therapy, fixed‐dose combination therapy, multi‐mechanistic treatment, pharmacokinetics, and pharmacodynamics. All articles considered relevant were included.

Results:

None of the existing migraine acute treatments as monotherapy effectively treat the key pathophysiological processes of migraine completely. Many patients do not achieve 2‐h pain freedom, which is key to avoiding migraine recurrence, medication overuse leading to chronification, and migraine‐related disability. The development of combination approaches has led to only two combinations with demonstrated superiority over their individual components: aspirin/acetaminophen/caffeine and sumatriptan/naproxen sodium. The latter is the most effective proven combination treatment because it targets peripheral activation of central pain pathways during the early migraine stages and central sensitization that develops later, independent of peripheral input. Other triptan/nonsteroidal anti‐inflammatory drug combinations with higher efficacy as monotherapies could be more effective than sumatriptan/naproxen sodium, particularly if their pharmacokinetic profiles align with the vasoactive mediators of peripheral and central sensitization that they target.

Conclusions:

Combination treatments with different mechanisms of action targeting key distinct pathophysiological processes of migraine may be more effective than monotherapies, particularly if their pharmacokinetic profiles are optimized to target those processes at the right time. Further research in this area is warranted.image

01 May 2026·JOURNAL OF COLLOID AND INTERFACE SCIENCE

Tailoring the structure of MIL-101(Fe) for co-delivery of anti-inflammatory therapeutic agents

Article

Author: Goscianska, Joanna ; Ejsmont, Aleksander ; Galarda, Aleksandra ; Warowicka, Alicja

Treating inflammation often requires the combined use of multiple agents due to the complexity of biological pathways. Metal-organic frameworks (MOFs), with adjustable structures and high loading capacities, offer a promising route for dual-drug delivery. However, designing MOF-based systems that can simultaneously incorporate and release two distinct anti-inflammatory compounds remains a challenge. In this study, MIL-101(Fe) materials were synthesized under varying temperatures and solvent volumes to tailor their physicochemical properties. Higher synthesis temperatures promoted the formation of more crystalline, microporous structures with well-defined octahedral particles, whereas lower temperatures favored defect-rich, less ordered frameworks. These structural features governed adsorption and enabled controlled release of naproxen sodium and curcumin, selected for complementary action mechanisms. Material synthesized at 110 °C with doubled solvent volumes displayed the most favorable porosity, V_micro/V_total = 0.5, and uniform morphology, achieving high co-adsorption capacity (468 mg/g for naproxen sodium, 160 mg/g for curcumin) along with sustained release (92% and 60% within 24 h at pH 6.8, respectively). Biological evaluation demonstrated that all systems suppressed the synthesis of inflammatory markers, including prostaglandins and IL-6. Notably, the hierarchically porous MIL-101(Fe) synthesized at 110 °C with a higher solvent volume exhibited the strongest COX-1 inhibition (38%), whereas the predominantly mesoporous sample obtained at 110 °C with the standard solvent volume showed greater COX-2 suppression (53%). Low cytotoxicity was observed at 200 μg/mL of the therapeutic agents-loaded carriers, with cell viability remaining over 90%. These findings highlight the potential of MIL-101(Fe) as a tunable carrier for synergistic anti-inflammatory substance delivery.

News (Medical) associated with Naproxen Sodium

23 Sep 2025

·www.einpresswire.com

FDA use of Real-World Evidence in Regulatory Decision Making

CLOZARIL (clozapine) NDA 019758 Heritage Life Sciences (Barbados) c/o Heritage Life Sciences Therapeutics (USA) Veterans Health Administration (VHA) medical and pharmacy records Descriptive study In FDA’s review of the effectiveness of the clozapine REMS, FDA conducted several analyses of clozapine registry patients, describing adherence to absolute neutrophil count monitoring, as specified by the clozapine REMS, and estimating the cumulative risk of severe neutropenia. The study results were included in the November 19 Joint Meeting of the Drug Safety and Risk Management and Psychopharmacologic Drugs Advisory Committee briefing package, where the committee voted to remove the clozapine REMS. Based on the advice from the Advisory Committee and the Agency’s re-evaluation, the Agency removed the clozapine REMS and issued a DSC. DSC August 27,2025 FDA Drug Safety Communication: FDA removes risk evaluation and mitigation strategy (REMS) program for the antipsychotic drug Clozapine (REMS release, labeling changes) Toprol-XL and Lopressor (Metoprolol), Inderal LA (propranolol), [beta blockers] Multiple NDAs Multiple sponsors Sentinel System Retrospective cohort study The results from a retrospective cohort study in Sentinel indicated an association between beta blocker use and hypoglycemia in pediatric populations. FDA approved safety labeling changes to describe the risk for hypoglycemia in pediatrics or individuals unable to communicate signs of hypoglycemia. This resulted in a labeling change. Beta Blockers Safety Communications & Labeling Changes (Sentinel Initiative), July. 25, 2025. FDA Labeling Change: Additional Language to Mitigate the Risk of Hypoglycemia Associated with Beta Blockers in Children Beta blockers | Sentinel Initiative Entyvio (vedolizumab) BLA 761359 Takeda Pharmaceuticals Sentinel System Descriptive study The results from a descriptive Sentinel study did not indicate an increased risk for Interstitial lung disease (ILD) in patients treated with vedolizumab or natalizumab for inflammatory bowel disease. However, there were other data from case reports from the medical literature and FDA FAERS. This resulted in FDA adding “interstitial lung disease, pneumonitis” to the Postmarketing Experience subsection of labeling. Entyvio Safety Communications & Labeling Changes (Sentinel Initiative), April 18, 2024. FDA Labeling Change: Vedolizumab & Interstitial Lung Disease (ILD) Prolia (Denosumab) BLA 125320 Amgen Medicare claims data Retrospective cohort study In FDA’s review of denosumab, an FDA retrospective cohort study in Medicare found an increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking this medication. This resulted in a DSC and addition of a Boxed Warning for an increased risk of severe hypocalcemia in patients with advanced chronic kidney disease. FDA added a boxed warning. DSC, January 19, 2024 (severe hypocalcemia). FDA Drug Safety Communication: FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab) Prolia label change, November 22, 2022. FDA Drug Safety Communication: FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia Anticoagulant, oral Multiple NDAs Multiple sponsors Sentinel System Retrospective cohort study FDA conducted a retrospective cohort study in the Sentinel System to examine severe uterine bleeding events requiring medical intervention in women treated with oral anticoagulants. The study found a risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions. This finding contributed to a class-wide label change for this risk with oral anticoagulants and that this should be assessed in females of reproductive potential and those with abnormal uterine bleeding. There was also a communication via the Sentinel initiative website. Oral Anticoagulants Safety Communications & Labeling Changes (Sentinel Initiative), January. 28, 2021. FDA Labeling Change: Oral Anticoagulants and Clinically Significant Uterine Bleeding Methotrexate, oral Multiple NDAs Multiple sponsors Sentinel System A chart confirmed analysis was conducted in one Sentinel Data Partner An FDA medical chart review analysis conducted in a Sentinel Data Partner, found the incidence of low-dose oral methotrexate wrong frequency dosing errors to be 0.4%. This resulted in adding the risk of improper dosing to Section 5 (Warnings and Precautions), removing an option for doses given every 12 hours for 3 days each week from Section 2 (Dosage and Administration). Oral Methotrexate (Sentinel Initiative), December. 17, 2021. FDA Labeling Change: Oral Methotrexate and Wrong Frequency Dosing Errors Singulair (montelukast) NDA 021409 Organon Sentinel System Retrospective cohort study Retrospective cohort studies conducted in the Sentinel system informed the re-evaluation of the benefits and risks of montelukast use. Considering the totality of evidence, including the negative Sentinel studies resulted in FDA strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics). There was also a communication via the Sentinel initiative website. Singulair Safety Communications & Labeling Changes (Sentinel Initiative), March. 3, 2020. FDA Requires Boxed Warning about Serious Mental Health Side Effects for Asthma and Allergy Drug Montelukast (Singulair); Advises Restricting Use for Allergic Rhinitis Hydrochlorothiazide (HCTZ)-containing products Multiple NDAs Multiple sponsors Sentinel System Retrospective cohort study An FDA conducted retrospective cohort study in the Sentinel System assessed the risk of non-melanoma skin cancer for patients treated with HCTZ-containing products. The study identified an association with an increased risk of non-melanoma skin cancer, predominantly for squamous cell carcinoma and in white patients taking large cumulative doses. These findings informed additions to adverse reactions and patient information sections of the labeling, and a communication via the Sentinel initiative website. HCTZ Safety Communications & Labeling Changes (Sentinel Initiative), August. 20, 2020. FDA Labeling Change: Hydrochlorothiazide and Non-Melanoma Skin Cancer Feraheme, infed, injectafer, monoferric, venofer (Parenteral Iron Products) Multiple NDAs Multiple sponsors Sentinel System Descriptive study An FDA Sentinel analysis characterized the frequency of IV iron utilization relative to live birth and stillbirth deliveries. The finding contributed to a class-wide labeling update for parenteral iron products to add new safety information to Section 8 (Use in Specific Populations, Pregnancy) of the label. This update describes the risk of severe adverse reactions to pregnant women and their fetus. There was also a communication via the Sentinel initiative website. Parenteral Iron Safety Communications & Labeling Changes (Sentinel Initiative) The class-wide labeling update regarding risks to pregnant women and their fetus was approved on September. 11, 2020. FDA Labeling Change: Parenteral Iron Products and Risk of Severe Adverse Reactions to Pregnant Women and their Fetuses Comtan, Stalevo (Entacapone) NDA 021485/ 20796 Orion Corporation VHA claims, medical records, and cancer registry Retrospective cohort study In FDA’s review of entacapone, an FDA conducted retrospective cohort study in the VA found no clear evidence of an increased risk of prostate cancer in patients treated with entacapone versus add-on dopamine agonist or monoamine oxidase inhibitor. This resulted in a DSC. Entacapone DSC, August 13, 2019 (no increase in prostate cancer risk). FDA Drug Safety Communication: FDA review finds no increased risk of prostate cancer with Parkinson's disease medicines containing entacapone (Comtan, Stalevo) Pradaxa (dabigatran) NDA 022512 Boehringer Ingelheim Pharmaceuticals, Inc Medicare claims data Retrospective cohort study In FDA’s review of dabigatran, an FDA conducted retrospective cohort study among Medicare patients, showed lower risks stroke and death but higher risk for gastrointestinal bleeding with PRADAXA compared to warfarin. FDA still considered Pradaxa to have a favorable benefit/risk profile and made no changes to the labeling. This resulted in a DSC. Dabigatran Drug Safety Communication, May 13, 2014 FDA Drug Safety Communication: FDA study of Medicare patients finds risks lower for stroke and death but higher for gastrointestinal bleeding with Pradaxa (dabigatran) compared to warfarin Enbrel (etanercept) BLA 103795 Amgen Inc. Sentinel System Descriptive study FDA conducted a drug utilization analysis of TNF alpha inhibitors in pregnant women in the Sentinel System. The study found that among pregnant women with a chronic inflammatory condition, there was a preference to use etanercept compared to other TNF alpha inhibitors. This assessment was one source of evidence considered for the Pregnancy and Lactation Labeling Rule (PLLR) Conversion Safety Labeling Change. There was also a communication via the Sentinel initiative website. ENBREL Safety Communications & Labeling Changes (Sentinel Initiative), July. 11, 2017. FDA Labeling Change: Etanercept (Enbrel) and Use in Pregnancy Gadolinium-based contrast agents (GBCA) Multiple NDAs Multiple sponsors Sentinel System Descriptive study Analyses on gadolinium retention were done with FDA Sentinel data and other data streams. These analyses, in part, resulted in class-wide updates to Section 5 (Warnings and Precautions) to include the risk of gadolinium retention in tissues, including the brain, for months to years, a medication guide, required manufacturers to conduct additional safety assessments. There was also a communication via the Sentinel initiative website. GBCAs Safety Communications & Labeling Changes (Sentinel Initiative), December. 19, 2017. FDA Warns that Gadolinium-Based Contrast Agents (GBCAs) are Retained in the Body; Requires New Class Warnings Comtan, Stalevo (entacapone) NDA 021485/ 20796 Orion Corporation Medicare claims data Retrospective cohort study FDA conducted a retrospective cohort study in Medicare to assess cardiovascular risk associated with entacapone use. FDA found no clear evidence of increased cardiovascular risk with entacapone. The study resulted in a publication and DSC. Entacapone DSC, October 26, 2015. FDA Drug Safety Communication: FDA review found no increased cardiovascular risks with Parkinson’s disease drug entacapone Movement Disorder Society Publication, 2013 . Benicar (olmesartan) NDA 021286 Daiichi Sankyo Medicare claims data Retrospective cohort study In FDA’s review of Olmesartan, an FDA conducted retrospective cohort study in Medicare found no clear evidence of increased cardiovascular risks associated with high dose use in diabetic patients. As a result, FDA’s recommendations for use of olmesartan (BENICAR, BENICAR HCT, AZOR, TRIBENZOR, and generics) in patients with diabetes remained the same. This resulted in a DSC and the addition of the study information in the labeling. Olmesartan DSC, June 24, 2014 (Medicare study results added to labeling). FDA Drug Safety Communication: FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required Benicar, Benicar hct (Olmesartan), Azor, Tribenzor (medoxomil) Multiple NDAs Daiichi Sankyo Inc. Mini-Sentinel and Medicare Retrospective cohort study In FDA’s review of Olmesartan, an FDA evaluation of the FDA Adverse Event Reporting System (FAERS) and the published literature found evidence of an association between olmesartan and sprue-like enteropathy. To evaluate an ARB class association FDA conducted a retrospective cohort study in Mini-Sentinel and Medicare. These study results did not support a class effect. This resulted in an FDA safety communication that Olmesartan-containing products can cause intestinal problems known as sprue-like enteropathy. Olmesartan Safety Communications & Labeling Changes (Sentinel Initiative), July. 3, 2013. FDA Approves Labeling Changes to Include Intestinal Problems (Sprue-Like Enteropathy) Linked to Blood Pressure Medicine Olmesartan Medoxomil Pradaxa (dabigatran) NDA 022512 Boehringer Ingelheim Pharmaceuticals, Inc Mini-Sentinel Retrospective cohort study In 2012, an FDA conducted retrospective cohort study in Mini-Sentinel evaluated new information about the risk of serious bleeding associated with use of dabigatran (PRADAXA) and warfarin (COUMADIN, JANTOVEN, and generics). The results indicated that bleeding rates associated with new use of Pradaxa did not appear to be higher than bleeding rates associated with new use of warfarin, which was consistent with observations from the large clinical trial used to approve Pradaxa. FDA issued a DSC to communicate the findings and a communication via the Sentinel initiative website. DSC November, 02,2012 FDA Drug Safety Communication: Update on the risk for serious bleeding events with the anticoagulant Pradaxa (dabigatran) Sentinel Initiative, October. 31, 2012. Update on the Risk for Serious Bleeding Events with the Anticoagulant Pradaxa (Dabigatran) Epogen, Procrit, Aranesp (Erythropoietin stimulating agents (ESA)) BLA 103234 and BLA 103951 Amgen Medicare claims data Retrospective cohort study In FDA’s review of the effects of a labeling change recommending lower doses of ESAs in dialysis patients, an FDA retrospective cohort study in Medicare which assessed the effects of the changes in reimbursement policy in addition to changes in the ESA’s drug labeling found that the risk of MACE and mortality was unchanged, and risk of stroke was reduced following the labeling change. In Black patients, there was a substantial reduction in MACE and mortality after the labeling change. A bundled comprehensive payment system for dialysis that includes the costs of ESAs, and a revised drug label that recommends more conservative dosing had no adverse effects on older dialysis patients covered by fee-for-service Medicare. This resulted in a publication. The labeling change regarding use in patients with chronic kidney disease (CKD) was approved on June 24,2011 JAMA Publication, 2016. Avandia (rosiglitazone) NDA 021071 GlaxoSmithKline Medicare claims data Retrospective cohort study FDA conducted a retrospective cohort study in Medicare that evaluated the risk of heart attacks in patients taking rosiglitazone. The study resulted in labeling changes and an update to the Risk Evaluation and Mitigation Strategy (REMS) to include a restricted access and distribution program for all three rosiglitazone products. This also resulted in two Drug Safety Communications (DSC). Rosiglitazone DSC, May 18, 2011 (imposition of REMS for rosiglitazone use). FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl Rosiglitazone DSC and labeling change, February 3, 2011 (Medicare results added to label). FDA Drug Safety Communication: Avandia (rosiglitazone) labeling now contains updated information about cardiovascular risks and use in certain patients Imitrex (sumatriptan), Treximet® (sumatriptan and naproxen sodium) NDA 020626/ 020080/ 020132/ 021926/ GSK Pregnancy registry Prospective registry study The Sumatriptan/Naratriptan/Treximet Pregnancy Registry collected data on fetal malformations and birth defects from in-utero exposure to sumatriptan (January 1996 to September 2012). A prospective study conducted by the Sponsor identified too few exposed pregnancy outcomes to support definitive conclusions about overall malformation risk or for making comparisons of the frequencies of specific birth defects. Section 8 of the label was updated to reflect that data from the prospective pregnancy exposure registry and other epidemiological studies of pregnant women did not show an increased frequency of birth defects or a consistent pattern of birth defects among women exposed to sumatriptan compared with the general population. Completed Pregnancy Registry Study (ClinicalTrials.gov ID NCT01059604) Sumatriptan and Naratriptan Pregnancy Registry Study IMITREX labeling update December 14, 2017: See Section: 8 USE IN SPECIFIC POPULATIONS, 8.1 Pregnancy TREXIMET labeling update April 28,2021: TREXIMET labeling update April 28, 2021: See Section: 8 USE INSPECIFIC POPULATIONS, 8.1 Pregnancy Amerge (naratriptan) NDA 020763 GSK Pregnancy registry Prospective registry study The Sumatriptan/Naratriptan/Treximet Pregnancy Registry collected data on adverse fetal outcomes from in utero exposure to naratriptan. Section 8 of the AMERGE labeling was updated to reflect that no definitive conclusions could be drawn from the registry and epidemiological studies regarding the risk of birth defects following exposure to naratriptan. AMERGE label update November 29, 2016 See Section: 8 USE IN SPECIFIC POPULATIONS, 8.1 Pregnancy Proton pump inhibitors (PPI) Multiple NDAs Multiple sponsors Medicare claims data Case-control study In FDA’s review of drugs repurposed for treating patients with COVID-19 or drugs being taken by patients with COVID-19, there was concern that PPI use might increase the risk of developing severe COVID-19. An FDA conducted case control study in Medicare compared new users of PPIs versus new users of histamine-2 receptor antagonists and found that PPIs were not associated with increased risk uncomplicated or complicated (ICU, mechanical ventilation, death) COVID-19 hospitalizations. This provided reassurance to FDA that regulatory action was not needed. This resulted in a publication. Pharmacotherapy publication, 2024 . Angiotensin-converting enzyme (ACE) Inhibitors (multiple) and angiotensin receptor blockers (ARB) (multiple) Multiple NDAs Multiple sponsors Medicare claims data Case-control study In FDA’s review of ACE inhibitors or ARBs, an FDA conducted case-control study in Medicare evaluated the effect of ACE inhibitors or ARBs on the risk of developing severe COVID-19 and found that use of these drugs was not associated with increased risk of hospitalized COVID-19 or COVID-19-related mortality. No labeling changes were warranted. This resulted in a publication. Journal of General Internal Medicine publication, 2021. EPOGEN, PROCRIT, ARANESP (Erythropoietin stimulating agents (ESA)) BLA 103234 and 103951 Amgen Medicare Retrospective cohort study FDA reviewed the effect of the REMS for ESA use for chemotherapy-induced anemia, during and after the discontinuation of the REMS, and conducted a restrospective cohort study in Medicare that showed that the REMS had minimal impact on ESA use or transfusion rates and that the removal of the REMS did not affect subsequent ESA use or blood transfusions. Study results provided reassurance that FDA's removal of the REMS had not led to increased ESA use or transfusions. This resulted in a publication. Pharmacoepidemiology Drug Safety publication, 2021 . LYBREL (ethinyl estradiol; levonorgestrel) NDA 021864 Pfizer Sentinel System Retrospective cohort study An FDA conducted retrospective cohort study evaluated the risk of venous thromboembolism (VTE) for extended cycle contraceptives to determine whether these posed a greater risk of VTE due to increased hormone exposure, compared to 28-day products. The study provided reassurance that VTE risk was not substantially different between traditional and extended use oral contraceptives. JAMA Publication 2018 Januvia (sitagliptin) NDA 021995 Merck Pregnancy registry Prospective registry study A prospective study conducted by the Sponsor in a pregnancy registry identified too few exposed pregnancy outcomes to support definitive conclusions about overall malformation risk or for making comparisons of the frequencies of specific birth defects. Section 8 of the labeling was updated to reflect that the data available for pregnant women exposed to sitagliptin were not sufficient to inform a drug- associated risk for major birth defects and miscarriage. JANUVIA label update February 9, 2018. See Section: 8 USE IN SPECIFIC POPULATIONS, 8.1 Pregnancy - Risk Summary Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalNDAClinical Result

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.

100 Deals associated with Naproxen Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D00970	-	-	-

R&D Status

Approved

10 top approved records.

to view more data

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 Jun 2011
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


NCT04015596 (CTgov)	Phase 4	Anxiety, Separation \| Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections \| Anxiety Disorders	2	Naproxen Sodium (Intervention)	trnrcqqfgj(cdqtdkceye) = uouvyixonr odkzcnwpug (unztcrdeas, xkyvvurxjn - atfgfdftjz) View more	-	20 May 2026
				Placebo (Placebo)	trnrcqqfgj(cdqtdkceye) = sfpiqcdokf odkzcnwpug (unztcrdeas, vhgpugtbva - vqkvcakipa) View more
NCT03699293 (CTgov)	Phase 4	Angina, Unstable \| Carotid Artery Diseases \| Hypertrophy, Left Ventricular ... View more	8	naproxen sodium 550mg tablet+Aspirin 81mg tablet (ASA and Naproxen)	onpdehrkse(ierunpuild) = pyuhxejkzl cjescvzpuj (rilbzktirx, 18.4) View more	-	14 May 2026
				celecoxib 200mg capsule+Aspirin 81mg tablet (ASA and Celecoxib)	yyyjawqzzo(rzqicnaqiq) = bedpplptrs kyifujrhha (xxnwuekxqn, 11.0) View more
NCT03879408 (CTgov)	Phase 2	Pain, Postoperative	290	placebo (Arm 1: Placebo)	otlxklnqnd(gapcvqqxsy) = ehhludxzyt hydbyrmqko (uuoiwwiang, 2.181) View more	-	05 Dec 2022
				Naproxen (Arm 2: Naproxen Sodium 440 mg)	otlxklnqnd(gapcvqqxsy) = ausesmfhpk hydbyrmqko (uuoiwwiang, 1.562) View more
NCT04066426 (CTgov)	Phase 4	Soft tissue rheumatism \| Myofascial Pain Syndromes	200	naproxen sodium+paracetamol+dexamethasone+codeine phosphate (Naproxen Sodium+Codeine Phosphate)	ldzgzptsra(kpoqqytfzi) = hrxrzeycpy itavugfswt (ucspxmzjaz, 1.86) View more	-	15 Feb 2021
				naproxen sodium+paracetamol+dexamethasone+codeine phosphate (Naproxen Sodium+Dexamethasone)	ldzgzptsra(kpoqqytfzi) = sxubsvpyna itavugfswt (ucspxmzjaz, 1.76) View more
NCT03570554 (CTgov)	Phase 2	Osteoarthritis, Knee	41	Naproxen (Naproxen)	orgyosbmml(jrgqqtuczd) = cmwjnxwfrm oevhzdkgtg (psdlkqtvlu, 5.46) View more	-	19 Jun 2020
				Acetaminophen (Acetaminophen ER)	orgyosbmml(jrgqqtuczd) = ffmorfikrj oevhzdkgtg (psdlkqtvlu, 5.46) View more
NCT02388191 (CTgov)	Not Applicable	Pain \| Contraception	119	Naproxen Sodium (Naproxen Sodium)	ahdfwofeww(kywcpirhux) = furqmiwsdt pjpujlbbya (iswzqcgnam, rexbjxbvmr - rsrngshaml) View more	-	22 Jun 2017
				Placebo tablet (Placebo)	ahdfwofeww(kywcpirhux) = sqxcsqwrrf pjpujlbbya (iswzqcgnam, imkssnmdht - nnbguhholx) View more
NCT02388191 (Pubmed \| Obstet Gynecol)	Not Applicable	Pain	118	Naproxen sodium	igmfmvjdvr(govhoncerp) = gqsczmsrze ypmtafbccy (unnjcmbzlf ) View more	-	01 Dec 2016
				Placebo	igmfmvjdvr(govhoncerp) = rdzxucrgub ypmtafbccy (unnjcmbzlf ) View more
NCT01165307 (iTOM, CTgov)	Phase 4	Menorrhagia	77	Naproxen sodium pills+Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills (Medical Therapy)	puejojwgok(rcvijmsshw) = qgqmssjozc kttwsznjkf (wtoawocrmj, pqhynfbrgc - kszcjqauls) View more	-	15 Nov 2016
				NovaSure® Radiofrequency Endometrial Ablation (Radiofrequency Endometrial Ablation)	puejojwgok(rcvijmsshw) = gwizibfzjg kttwsznjkf (wtoawocrmj, xzikrkqgdh - gjjvnbelip) View more
NCT01090050 (CTgov)	Phase 4	Migraine Disorders	56	Sumatriptan/Naproxen Sodium (Sumatriptan/Naproxen Sodium)	fadmvjbhny(tzchmzkflo) = vthqzrhxui klswnycbsg (zzijirnoak, 32.9) View more	-	03 Jul 2013
				Naproxen Sodium (Naproxen Sodium)	fadmvjbhny(tzchmzkflo) = rdjpmgrfbf klswnycbsg (zzijirnoak, 36.2) View more
NCT01300546 (CTgov)	Phase 4	Migraine Disorders	40	Sumatriptan/Naproxen Sodium (Sumatriptan/Naproxen Sodium)	eawklsjqwd(qoqtswrsro) = vdxcyldsjc frtuyfaaid (vpfecycdxr, 34.80) View more	-	21 May 2013
				Naproxen Sodium (Naproxen Sodium)	eawklsjqwd(qoqtswrsro) = iqxcilipzg frtuyfaaid (vpfecycdxr, 36.48) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis

Naproxen Sodium

Overview

Basic Info

Structure/Sequence

Related

External Link

R&D Status

Clinical Result

Translational Medicine

Deal

Core Patent

Clinical Trial

Approval

Regulation