Pozen awaits FDA decision on migraine drug

Pozen is now close to the receipt of a $20 million milestone windfall from GlaxoSmithKline, which is due to be paid to Pozen upon FDA approval of the drug.

The new drug application for Trexima, licensed to GlaxoSmithKline, comes days after the company announced that it would drop its development of its other migraine drug, MT100, amid concerns raised by the FDA that it contained a component that is associated with a condition called tardive dyskinesia, an involuntary neurological movement disorder. The company said at that time that its decision to drop MT100 was partly due to the good performance of Trexima in studies.

Dr Marshall Reese, executive vice president, product development stated, “We are pleased to submit the Trexima NDA ahead of schedule and within four months from the database lock on the last pivotal clinical study for the NDA. This has been a well-executed development program with good collaborative efforts put forth by team members from both GlaxoSmithKline (GSK) and Pozen.”

Migraine affects more than 28 million people in the Unites States alone, of which roughly three out of four migraine sufferers are women. Migraine can be disabling and sufferers may miss days of work, lose time with family and friends, and be unable to pursue basic daily activities.