FDA panel rejects menopause drug

FDA voted 2-12 against approval for an investigational, oral, twice-daily formulation of gabapentin (Sefelsa, Depomed) to treat moderate to severe vasomotor symptoms due to menopause.

Sefelsa is the proposed trade name for the medication and was formerly referred to as Serada. 

“FDA’s overwhelming decision regarding the risks overweighing the benefits of using Depomed for the treatment of hot flashes and other symptoms of menopause reaffirms its goal to only approve high-quality agents that have indicators to show that they are only beneficial but can be also be safely used in the general population,” said Formulary Advisor Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, in Webster, Texas.

Data presented to FDA’s Reproductive Health Drugs Advisory Committee included results from the phase 3 clinical program, which enrolled 1,706 patients in 3 studies.

“The weak results that came from 3 studies . . . which demonstrated non-significant reduction in hot flash along with the side-effect profile of the medication will be taken into consideration when FDA does give its final decision within the next few months,” Dr Farinde said.

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.