Vivus' EvaMist NDA accepted by US FDA

US drugmaker Vivus says that its New Drug Application for EvaMist, its novel, once-a-day, proprietary, first-in-class, transdermal estradiol spray, was accepted for review by the US Food and Drug Administration as a new treatment for vasomotor symptoms associated with menopause.

The firm announced positive results from a pivotal Phase III clinical trial of EvaMist earlier this year, showing a statistically-significant reduction in the number and severity of moderate and severe hot flashes for all three doses tested.

Vivus said that EvaMist is a small, hand-held, simple-to-use spray designed to provide an easy and convenient means to deliver a preset dose of estradiol via the skin. According to the firm, the treatment is fast-drying, non-irritating and invisible after application. Studies have shown that, once administered, EvaMist's formulation is not affected by washing and does not transfer to other people, Vivus noted.