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Pozen Secures FDA OK for Migraine Drug

Shares soar after Treximet finally wins regulatory approval.

The wait is over for

Pozen Pharmaceuticals


investors, as the Food and Drug Administration has approved the biotech company's previously delayed Treximet.

Pozen announced the approval after the market close Tuesday, sending shares soaring by more than 40% in off-hours trading to open Wednesday up $4.07, or 38.7%, at $14.60. Treximet is a migraine treatment that combines partner


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Imitrex with an anti-inflammatory pain reliever.

Treximet has been under review by the FDA since 2005. In August, the agency put off approval, asking for more clinical data, which Pozen provided last fall. Shares were trading as high as $17.45 the day before that August approvable letter slashed the stock by 45% to $9.93.

Earlier in April, Pozen shares hiccupped on news that Glaxo received a warning letter from the FDA regarding study data it had omitted in submissions to the agency on a different venture, its diabetes drug Avandia. But worry that Glaxo's FDA issues might carry over proved to no avail.

The approval is timely for Glaxo, which faces generic-drug pressure this year for Imitrex. Pozen will receive expense-free royalties on Treximet.

Glaxo's shares rose to open Wednesday up 0.9% at $42.63.