Pozen Launches Another Bid To Win FDA Approval For Migraine Drug
Posted November 10, 2006
CHAPEL HILL, N.C. — Pozen
has mounted another attempt to receive approval from the Food and Drug Administration for its migraine drug that it developed in partnership with GlaxoSmithKline.
On Thursday, Pozen (NASDAQ: POZN) said it had submitted a full response to the FDA in response to the FDAs rejection of the drug called Trexima earlier this year. The FDA expressed safety concerns about Trexima.
The FDA has six months to consider Pozens response, the company said.
In September, Pozen and GSK reported that new test data was positive for Trexima.
The FDAs rejection of Trexima earlier this year sent Pozens stock down more than 60 percent.
At a migraine conference in London, Pozen and GSK said the new test results suggest Trexima may address an unmet need among migraine sufferers, who frequently cite inconsistent effectiveness as a reason for their dissatisfaction with their medicine. The results also indicate Trexima was generally well tolerated across both studies.
Pozen has already received $35 million in milestone payments from GSK for Trexima.