Pozen says FDA sets 6-mo review for migraine drug

POZEN Announces Trexima(TM) (Sumatriptan Succinate and Naproxen Sodium) Amended Response Accepted for Review by FDA
Thursday March 22, 4:54 pm ET

CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ: POZN - News), today announced the amended response to a previous FDA approvable letter for Trexima(TM) has been accepted for review by the U.S. Food and Drug Administration (FDA). Trexima is the proposed brand name for the combination of sumatriptan succinate, formulated with RT Technology(TM), and naproxen sodium, in a single tablet for the acute treatment of migraine. The FDA has also notified POZEN that it expects a Class II review (six months), which could result in a new decision date of August 1, 2007. Pending FDA approval, the product could be available to patients in the second half of 2007.

LOS ANGELES, March 22 (Reuters) - Pozen Inc. (POZN.O: Quote, Profile , Research) said on Thursday the U.S. Food and Drug Administration has accepted for review the company's amended marketing application for experimental migraine drug Trexima.
The FDA expects a six-month review, which could result in a new decision date of August 1, the company said.
Shares of Pozen were up 7.5 percent at $15.70 in after hours trading.
The FDA issued a so-called approvable letter for Trexima last June but decided Pozen's initial response to the letter was incomplete and requested more information in December, delaying the drug's final approval.
Pozen is developing the drug in a partnership with Britain's GlaxoSmithKline Plc (GSK.L: Quote, Profile , Research).
Trexima combines Glaxo's existing migraine drug Imitrex with the painkiller naproxen, an older non-steroidal, anti-inflammatory drug, or NSAID.
Imitrex is part of a class of drugs known as triptans used to stop but not prevent migraines. The drugs aim to relieve pain by allowing better blood flow. Adding naproxen helps extend the relief.