Noven's Brisdelle is first non-hormonal treatment for menopausal hot flashes to be approved by FDA

The US Food and Drug Administration on Friday (June 28) approved Noven Pharmaceuticals’ Brisdelle (paroxetine) to treat moderate to severe hot flashes (vasomotor symptoms; VMS) associated with menopause.

This is a surprise decision for Noven, a subsidiary of Japan’s Hisamitsu Pharmaceutical (TYO: 4530), given that an FDA advisory panel recently voted 10-four against approval of paroxetine for hot flashes associated with menopause, with the majority saying the drug's benefit was not sufficient to offset its risks (The Pharma Letter March 3). Also, earlier this month, the FDA issued a complete response letter to Depomed (Nasdaq: DEPO) for Sefelsa, its investigational, oral, twice daily formulation of gabapentin to treat moderate to severe vasomotor symptoms due to menopause (TPL June 3).

Prior to the approval of Brisdelle, hormone therapy was the only FDA-approved treatment for VMS. Many women are unable or unwilling to take hormone therapy to treat their VMS associated with menopause, often leaving symptoms untreated. There are a variety of FDA-approved treatments for hot flashes, but all contain either estrogen alone or estrogen plus a progestin. Noven is a stand-alone operating subsidiary of Japan-based Hisamitsu Pharmaceutical.