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FDA Advisors Say ‘No’ to Menopause Drug Sefelsa (Gabapentin)
Agency review scheduled for May (Mar. 4)
The FDA’s Reproductive Health Drugs Advisory Committee (RHDAC) has voted 2 to 12 against approval for Sefelsa — an investigational, oral, twice-daily formulation of the epilepsy drug gabapentin — to treat moderate-to-severe vasomotor symptoms due to menopause. The committee also voted 13 to 1 that the drug’s developer, Depomed, Inc., had failed to prove convincingly that Sefelsa worked.
Data presented at the advisory committee meeting included results from a phase III clinical program, which enrolled 1,706 menopause patients in three studies.
The FDA will consider the committee’s recommendation in its review of the new drug application (NDA) for Sefelsa, which was submitted on July 31, 2012, although the FDA is not bound to follow it. The Prescription Drug User Fee Act (PDUFA) date for Sefelsa is May 31, 2013.
Vasomotor symptoms include hot flashes and night sweats. A hot flash is a sudden flushing and sensation of heat caused by dilation of skin capillaries. Currently, the leading prescription drug product for the treatment of hot flashes associated with menopause is hormone replacement therapy (HRT). HRT involves the administration of the hormone estrogen, either alone or in combination with the hormone progestin.
A short-acting formulation of gabapentin (Neurontin, Pfizer) was approved in 1993.
Sefelsa is the proposed trade name for the new drug, which was formerly called Serada. Depomed, Inc. already markets gabapentin for the treatment of shingles-related pain under the trade name Gralise.