A special committee of the Food and Drug Administration refused to back Pozen Pharmaceuticals’ MT100 migraine drug on Thursday.

The FDA rejected the drug in May of 2004. Its Peripheral & Central Nervous System Drugs Advisory Committee reviewed results again from data collected on MT100 and ruled that results from trials were not “sufficient to allow exposure of migraine patients to the risk of tardive dyskinesia,” a side effect that includes tongue and mouth movements.

“The amount of benefit perceived or demonstrated, so far–is not sufficient given the perceived risk,” said Karl Kieburtz, the acting chair of the committee who works at the University of Rochester.

FDA “must ask for extreme rigor with this particular drug,” added committee consultant Michael Welch of the Chicago Medical School.

Pozen (Nasdaq: POZN) stock dropped more than 5 percent, or 43 cents, to $7.97 on the news, which was announced before the markets closed.

John Plachetka, chief executive officer of Pozen, told Reuters that “we didn’t lose any ground today. The drug was not approved last year.”

“I don’t want to speculate on what we’re going to do,” he added.
Pozen had appealed FDA rejection of the drug.

“I think there is an uncertainty about whether or not the nausea or no nausea populations have been demonstrated,” added committee industry representative Roger Porter, a former Wyeth vice rpesident of clinical research and development. “The company should not mislead itself by a subgroup analysis upfront that necessarily takes them down the wrong path.”

Some committee members also urged further study to quantify the risk of tardive dyskinesia with MT 100, the FDA said in its statement.

The committee review came as a result of a series of meetings held between the FDA and Pozen late last year.

“The FDA stated in a recent memo that it is possible that MT 100 may not be approvable if the benefits of the drug do not, in FDA’s opinion, outweigh the risks of MT 100, including the risk of tardive dyskinesia, even if FDA eventually determines that MT 100 meets the efficacy requirements for a combination migraine agent,” Pozen said in a statement issued in December.

The FDA issued a non-approvable letter to Pozen in May of 2004. The news cut more than half off Pozen’s stock price at the time, which was more than $17.

For the complete FDA statement, see: www.fdaadvisorycommittee.com/FDC/AdvisoryCommittee/Stories/080405_MT100R.htm