Pozen answers FDA questions on Treximet

CHAPEL HILL, N.C. Pozen has submitted study results to answer safety concerns the Food and Drug Administration had about its migraine drug, according to published reports. Pozen also announced that the FDA has tentatively accepted a new name for the pill, changing it from Trexima to Treximet.

After satisfying questions about Treximet’s potential to cause heart attacks, stroke and genetic damage, Pozen expected the drug to pass regulatory scrutiny in August. But the FDA raised new concerns, this time about lab test results that suggested Treximet’s two ingredients may be toxic when taken together.

In October, Pozen submitted additional information about the test that raised the toxicity concerns. Now the company has followed up with study results that indicate the drug didn’t cause genetic abnormalities in patients who took the pill for seven days.

Pozen has been developing the drug with GlaxoSmithKline, who is hoping the drug will be approved before the end of the year to help keep its control of the migraine drug market after its drug Imitrex goes off patent at the end of the year.

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