FDA Says No to Nonhormonal Drug for Hot Flashes

Megan Brooks


June 03, 2013

The US Food and Drug Administration (FDA) has declined to approve Depomed Inc's new drug application for Sefelsa, an oral, twice-daily formulation of gabapentin to treat menopausal vasomotor symptoms, the company announced June 1.

The complete response letter (CRL) was "expected in light of the Sefelsa FDA Advisory Committee meeting," Jim Schoeneck, president and chief executive officer of Depomed said in a statement.

On March 4, 2013, the FDA's Committee for Reproductive Health Drugs voted by a wide margin that the drug should not be approved for menopausal hot flashes.

As reported by Medscape Medical News, the panel was unimpressed by the drug's limited efficacy in controlling hot flashes in light of its adverse cognition and other central nervous system effects.

Panel member Kathryn M. Curtis, PhD, from the Centers for Disease Control and Prevention, Atlanta, Georgia, said, "We all understand the huge need for a nonhormonal treatment for [vasomotor symptoms], but approving a drug that has a very modest effect is almost misleading to those women who are really looking for something that is very effective."

On the basis of the panel's decision and the CRL, Depomed said it does not currently intend to further invest in Sefelsa for menopausal symptoms.

In 2011, the FDA approved Depomed's once-daily, extended-release formulation of gabapentin tablets (Gralise) for treatment of postherpetic neuralgia.


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