Depomed slams brakes on hot-flash drug after FDA advisers vote to reject

Depomed ($DEPO) took a 10% hit on its stock price mid-day Monday after FDA advisers turned thumbs down on the company's drug to ease symptoms of hot flashes in a lopsided "no" vote. In a 12 to 2 vote, the outside advisers voted against recommending an approval for Sefelsa, concluding that the company had failed to demonstrate that the drug worked as billed. And in a tough day for developers, the same committee also rejected a new therapy for hot flashes from Hisamitsu in the afternoon. 

The Depomed vote may have taken some analysts by surprise, especially as staff remarks on the drug appeared somewhat positive just days ago. But faced with a large red stop sign, pending a formal decision by the agency, Depomed slammed the brakes on any further spending on the therapy.

"We recognize and appreciate the concerns that were raised by the members of the advisory committee," says CEO Jim Schoeneck. "Based on today's meeting we believe the hurdles for approval of a non-hormonal treatment for hot flashes remain high. Until we believe there is a positive direction for Sefelsa, we will cease all spending relating to the product candidate." 

Aside from failing to demonstrate clear signs of efficacy, advisers also appeared reluctant to push for an OK in the face of adverse events that include dizziness, sleepiness and nausea, as well as an increased risk of suicide, according to a Reuters report.

Depomed rested its case on a Phase III study of the drug, an extended-release form of gabapentin, which has been approved in the past for shingles-related pain.

The same committee voted Monday afternoon to recommend against an approval for Hisamitsu's peroxitine mesylate. The drug is currently sold for depression, panic disorder and other conditions, but may not add hot flashes to the label anytime soon. The FDA can overturn the adcomm vote, but rarely does..

- here's the press release
- read the story Reuters
- here's the Bloomberg report on the Hisamitsu vote

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