Pozen responds to safety concerns for migraine drug
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Pozen responds to safety concerns for migraine drug
Friday November 10, 9:43 am ET
Pozen Inc. on Thursday filed a full response to safety questions raised by the U.S. Food and Drug Administration about migraine treatment Trexima, which it is developing with GlaxoSmithKline.
The Chapel Hill pharmaceutical firm received an approvable letter from the FDA in June indicating that Trexima was "effective as an acute treatment for migraine headaches," but that the agency wanted more safety information on the treatment - a request that could have require more drug trials.
Pozen said Thursday that it has responded to those safety concerns and that the FDA now has up to six months to review the new information.
An FDA approval of the drug based on the additional safety information would spare Pozen and GSK the time and expense of further clinical trials.
Pozen (Nasdaq: POZN - News) halted development of MT 100, another migraine drug, in August following an FDA committee's recommendation against approval because of safety concerns.
London-based GSK (NYSE: GSK - News) has dual U.S. headquarters in Research Triangle Park and Philadelphia. The company employs about 5,600 Triangle workers.
Published November 9, 2006 by the Triangle Business Journal
Pozen responds to safety concerns for migraine drug
Friday November 10, 9:43 am ET
Pozen Inc. on Thursday filed a full response to safety questions raised by the U.S. Food and Drug Administration about migraine treatment Trexima, which it is developing with GlaxoSmithKline.
The Chapel Hill pharmaceutical firm received an approvable letter from the FDA in June indicating that Trexima was "effective as an acute treatment for migraine headaches," but that the agency wanted more safety information on the treatment - a request that could have require more drug trials.
Pozen said Thursday that it has responded to those safety concerns and that the FDA now has up to six months to review the new information.
An FDA approval of the drug based on the additional safety information would spare Pozen and GSK the time and expense of further clinical trials.
Pozen (Nasdaq: POZN - News) halted development of MT 100, another migraine drug, in August following an FDA committee's recommendation against approval because of safety concerns.
London-based GSK (NYSE: GSK - News) has dual U.S. headquarters in Research Triangle Park and Philadelphia. The company employs about 5,600 Triangle workers.
Published November 9, 2006 by the Triangle Business Journal
posted by B at 7:47 PM
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