BETHESDA, Md. (
) -- An advisory panel convened by the U.S. Food and Drug Administration meets today to review an new therapy for menopausal hot flashes developed by
(DEPO - Get Report)
Joining me this morning to cover the Depomed FDA panel live blog are Zacks analyst Jason Napodano and biotech investor and TheStreet contributor Aafia Chaudhry. Jason and Aaafia are bullish and bearish on Depomed, respectively, so I'm hoping for some fireworks between the two along with insightful analysis of the panel's proceedings.
The Depomed drug being reviewed today is Sefelsa, a long-acting form of the generic drug gabapentin, which is currently approved to treat shingles-related nerve pain.
An FDA review posted to the agency's web site Thursday found that Sefelsa does provide some relief to menopausal women but also questioned the durability of the drug's effect. Studies conducted demonstrated Sefelsa can lower the incidence of hot flashes for four weeks but response falls off when measured at 12 or 24 weeks, FDA said.
The FDA also raised concerns about Sefelsa's link to patient reports of suicidal thoughts.
Experts on the FDA's advisory panel are being asked to review the efficacy and safety data for Sefelsa and vote on whether or not to recommend the drug for approval. The final decision on approval rests with FDA. The agency is expected to make its decision known by May 31.
-- Reported by Adam Feuerstein in Boston.