Hot Flash from FDA Advisors

Hot Flash from FDA Advisors
Hot Flash from FDA Advisors
Suzanne B. Robotti
Suzanne B. Robotti Executive Director

Is it hot in here or is it me? That’s the not-so-funny punch line of menopause. 75% of the 32 million women experiencing menopause each year suffer from hot flashes. Hormone replacement therapy (HRT) offered relief for hot flashes and the full spectrum of menopause symptoms, but they have high risks.

Reuters reported that two companies were in test for the first non-hormonal drugs that reduce the frequency and severity of hot flashes, but in early March 2013, an advisory panel of the FDA voted against approving them. The FDA determined that neither offered enough benefits to offset the risks. The 2 companies were Hisamitsu Pharmaceutical Co Inc’s subsidiary Noven Pharmaceuticals Inc. and Depomed Inc.

Depomed’s drug Sefelsa is a long-acting version of the epilepsy drug gabapentin. In clinical it was not only ineffective but came along with a handful of side effects that were nearly as bad as the hot flashes. It also increased the risk of suicide.

Noven’s drug was a low dose antidepressant similar to Paxil. In its trials it’s efficacy was unclear because many of those taking placebos improved also.

Sadly for the Flash Brigade (which I was finally released from myself a year or two ago), we don’t have a non-hormonal drug solution for hot flashes yet.

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