FDA Approves Treximet for Migraine in Teens
FDA Approves Treximet (sumatriptan and naproxen sodium) for Migraine in Pediatric Patients
MORRISTOWN, NJ – May 15, 2015 – Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX), a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Treximet (sumatriptan and naproxen sodium) for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura.1
Treximet is the first approved combination prescription medicine, and the first to contain sumatriptan, for the treatment of acute migraine attacks in pediatric patients.1 The two medicines – sumatriptan and naproxen sodium – in combination provide more effective, sustained control of the pain and associated symptoms of migraine compared to either medicine taken alone.2,3 Approval came after the FDA’s review of pivotal phase 3 safety and efficacy clinical trial, plus long-term safety and pharmacokinetic data, demonstrating that Treximet is significantly more effective than placebo in treating migraine in pediatric patients and has a favorable safety profile similar to that of Treximet for adults.4,5,6 Treximet carries a boxed warning noting cardiovascular and gastrointestinal risks. For full safety and efficacy information, please see the prescribing information. While Treximet has been approved for the acute treatment of migraine in adults since 2008, the FDA set a priority review of the supplemental New Drug Application based, in part, on the need for options among this specialty population. An estimated eight percent to 23 percent of all pediatric patients 11 years and older suffer from migraine7, but treatment options have been limited, especially compared to adults.
“Until now, pediatric migraine sufferers have not had the same number of treatment options compared to adults to manage the potentially debilitating effects of acute migraine,” said Merle Lea Diamond, M.D., president and managing director of the Diamond Headache Clinic and consultant to Pernix. “As many as one out of five teens suffers from migraines, and their burden goes well beyond the pain, as migraines can also adversely affect their social growth and their efforts in school.”
“We are pleased with FDA’s decision and look forward to bringing migraine relief to pediatric patients by making the new Treximet dose available in the third quarter of this year,” said Doug Drysdale, Chairman and Chief Executive Officer of Pernix. “This expanded indication exemplifies our strategy to expand the reach of our current product portfolio to address additional underserved therapeutic areas, thereby adding value for patients and shareholders alike.”
The recommended dose for pediatric patients 12 years of age and older is a single tablet of Treximet 10/60 mg (sumatriptan 10 mg and naproxen sodium 60 mg) per 24-hour period and the maximum recommended dose is 85/500 mg per 24-hour period.1 The recommended dose for adults is a single tablet of Treximet 85/500 mg.1
Treximet was first approved by the U.S. Food and Drug Administration (FDA) in April 2008 for the acute treatment of migraine attacks, with or without aura, in adults. The product is formulated with POZEN’s patented technology of combining a triptan with a non-steroidal anti-inflammatory drug (NSAID) and GlaxoSmithKline’s (GSK) RT Technology™. Treximet has been shown to provide superior sustained pain relief compared to placebo and to both of the single mechanism of action components. In clinical trials, Treximet provided a significantly greater percentage of adult patients with migraine pain relief at two hours compared to sumatriptan 85 mg or naproxen sodium 500 mg alone. In addition, Treximet provided more patients sustained migraine pain relief from two to 24 hours compared to the individual components.
About Pernix Therapeutics
Pernix Therapeutics is a specialty pharmaceutical business with a focus on acquiring, developing and commercializing prescription drugs primarily for the U.S. market. The Company targets underserved therapeutic areas such as CNS, including neurology and pain management, and has an interest in expanding into additional specialty segments. The Company promotes its branded products to physicians through its two Pernix sales forces and markets its generic portfolio through its wholly owned subsidiaries, Macoven Pharmaceuticals, LLC and Cypress Pharmaceutical, Inc.
- Treximet Prescribing Information. Updated May 2015.
- Brandes JL, Kudrow D, Stark SR, et al. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA 2007; 297(13): 1443–1454.
- Smith TR, Sunshine A, Stark SR, et al. Sumatriptan and naproxen sodium for the acute treatment of migraine. Headache 2005; 45:983-991.
- Derosier, FJ. Randomized Trial of Sumatriptan and Naproxen Sodium Combination in Adolescent Migraine. Pediatrics 2012.
- MacDonald SA, Hershey AD, Pearlman E. Long-Term Evaluation of Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents. Headache 2011; 51:1374-1387.
- Berges A, et al. Pharmacokinetics, Safety, and Tolerability Following the Administration of a Single Dose of a Combination Tablet Containing Sumatriptan and Naproxen Sodium in Adolescent Patients With Migraine and in Healthy Adult Volunteers. Clinical Pharmacology in Drug Development 2012; 1(3):85-92.
- Lewis D, Ashwal S. Hershey A. Hirtz D, Yonker M. Silberstein S; American Academy of Neurology Quality Standards Subcommittee; Practice Committee of the Child Neurology Society. Practice parameter: pharmacological treatment of migraine headache in children and adolescents: report of the American Academy of Neurology Quality Standards Subcommittee and the Practice Committee of the Child Neurology Society. Neurology 2004; 63(12):2215- 2224.
Source: Pernix Therapeutics Holdings, Inc.
Posted: May 2015
- Treximet (sumatriptan and naproxen sodium) Tablets Approved by FDAfor Acute Treatment of Migraine - April 16, 2008
- Pozen Submits Human Lymphocyte Study for Treximet (Formerly Known as Trexima) - January 16, 2008
- Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA - November 1, 2007
- Pozen Submits Response to Approvable Letter for Trexima - October 15, 2007
- Pozen Plans to Submit Response to Approvable Letter For Trexima Within the Next Ten Days - October 5, 2007
- FDA Issues Second Approvable Letter for Trexima - August 2, 2007
- Pozen Announces Trexima (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA - March 22, 2007
- Pozen Expects to Submit Revised Response to Trexima Approvable Letter by Year End - December 13, 2006
- Pozen Submits Full Response to FDA Approvable Letter For Trexima - November 9, 2006
- Pozen to Submit Full Response to Trexima Approvable Letter During the Fourth Quarter - July 31, 2006
- Pozen Inc. and GlaxoSmithKline Report Receipt of Approvable Letter for Investigational Migraine Treatment - June 9, 2006
- GlaxoSmithKline and POZEN Announce Trexima (Sumatriptan Succinate and Naproxen Sodium) New Drug Application Accepted for Review by FDA - October 11, 2005
- POZEN Submits New Drug Application for Trexima (Sumatriptan Succinate and Naproxen Sodium) for the Acute Treatment of Migraine - August 8, 2005
More News Resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
- Monthly Update Archive
Subscribe to our Newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.