Oh, What a Relief for Pozen, GSK – FDA Approves Migraine Drug; Pozen Shares Surge

Chapel Hill, N.C. — After years of trying and multiple submissions to regulators, Pozen Pharmaceuticals and GlaxoSmithKline received U.S. Food and Drug Administration approval for the migraine drug Treximet on Tuesday.

Investors swarmed to Pozen (Nasdaq: POZN) stock in after-hours trading Tuesday night, driving the share price up 37 percent, or $3.97, to $13.50. It is Pozen's first drug approval.

GSK had partnered with Pozen to produce the drug, which utilizes proprietary technology from Pozen to combine a pain reliever based on triptans and an anti-inflammatory pain reliever.

GSK (NYSE: GSK) has paid Pozen more than $35 million to develop the compound.

The drug’s approval could also be good news for the more than 29 million Americans who suffered from migraines. The anti-inflammatory drug in the new pill is naproxen, a non-sterodial anti-inflammatory drug. Treximet also includes GSK’s Imitrex, a billion-dollar-selling drug that faces generic competition.

The FDA approved the drug after a review of data that showed Treximet had “a significantly greater percentage of patients migraine relieve at two hours” compared to being treated by the drugs in Treximet separately.

Pozen shares closed up 6.4 percent at $10.53 Tuesday based on Wall Street expectations that Treximet would be approved.

"Migraine patients want their medicine to work early, and to continue to provide relief," said Stephen Silberstein, professor of neurology and director of the Jefferson Headache Center at Thomas Jefferson University and an investigator who participated in clinical trials, in a statement distributed by GSK. "The FDA approval of Treximet is good news for migraine patients because clinical trials showed that Treximet produced sustained migraine pain relief for a significant number of patients."

More than 2,900 migraine sufferers were studied in the last two tests.

Pozen recently submitted data to address FDA concerns about genotoxic “aberrations” in human volunteers. The FDA rejected the drug lin 2007, citing genotoxic impact on hamsters that had been used in tests. The drug had been called Trexima.

Pozen has been trying to win approval for the drug since 2005. The FDA expressed concerns about genotoxicity, or damage to DNA, that was “seen for the combination of naproxen sodium and sumatriptan,” Pozen said in a letter in August. Those are the ingredients Pozen has combined in one pill. The genotoxicity was observed in one of four studies, Pozen said.

In an earlier review of the drug, the FDA expressed concern about cardiovascular side effects.