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Combo migraine drug gets go-ahead.

GlaxoSmithKline and developmental partner Pozen have received marketing approval for a combination drug for short-term treatment of migraine attacks with or without aura in adults, ending a nearly 3-year regulatory review process.

GlaxoSmithKline (GSK) said it received approval last month from the Food and Drug Administration for Treximet (sumatriptan / naproxen sodium), formerly called Trexima. At press time, the company said the drug likely would be available in the United States by mid-May. The United Kingdom-based company said it has no plans to seek approval of Treximet in other countries. "Certainly, doctors who treat migraine patients, some of those are primary care physicians," GSK said.

The company and Pozen, based in Chapel Hill, N.C., signed a licensing agreement for Treximet in June 2003 and filed a new drug application in August 2005. Final regulatory clearance was delayed by two FDA letters, the first in which it cited concerns with cardiotoxicity, and the second in which the agency raised concerns about potential implications of a preclinical in vitro chromosomal aberration study.

The agency requested an alternative genotoxicity test and/or a test in human subjects at plasma concentrations that would mimic those seen in people taking the indicated dose of Treximet.

Pozen responded to the second letter Oct. 15, and the agency deemed it a "complete response" several weeks later. At the time, the companies requested a 2-month review, but the FDA decided on a 6-month review schedule instead.

Getting the product to market quickly is a key priority for GSK's migraine franchise as the company's Imitrex (sumatriptan) is slated to lose exclusivity this year. On Jan. 15, Pozen said it had submitted findings from a short-term genotoxicity study to the FDA, which showed no chromosomal aberrations were induced in peripheral blood lymphocytes when Treximet was administered for 7 days.

In addition, Pozen said, the FDA accepted the brand name Treximet for the candidate. GSK said it changed the drug name from Trexima to avoid confusion with other marketed products.

GSK claims Treximet is the only migraine product designed to target multiple mechanisms of migraine by combining a triptan and an anti-inflammatory in a single tablet. The tablet comprises 85 mg of sumatriptan and 500 mg of naproxen sodium.

In clinical testing, the combination provided migraine pain relief to a significantly greater percentage of patients at 2 hours than either of the components given alone, GSK says. More patients also reported sustained pain relief between 2 and 24 hours with the combination than they did with either individual component.

Treximet may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. The companies said this risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Treximet contains a nonsteroidal anti-inflammatory drug.

"The Pink Sheet" is published by Elsevier.

BY JOSEPH HAAS

"The Pink Sheet"

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Title Annotation:NEWS FROM THE FDA
Author:Haas, Joseph
Publication:Family Practice News
Date:May 15, 2008
Words:482
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