Vivus' Evamist sees strong Ph III data

US drugmaker Vivus has reported positive results from a pivotal Phase III clinical trial of Evamist, its investigational estradiol metered-dose transdermal spray being developed for the treatment of vasomotor symptoms associated with the menopause.

According to the California-based firm, the study showed a statistically-significant reduction in the number and severity of moderate and severe hot flashes for all three doses tested.

The evaluation, which was conducted at 43 clinical sites in the USA, was a 12-week, randomized, double-blind, placebo-controlled study of 457 menopausal women. Patients were randomized into three treatment arms each administering a different dose with one, two or three sprays. The product is a novel, once-a-day proprietary, first-in-class transdermal spray that delivers a pre-set dose of estradiol via the skin. Studies have shown that, once administered, Evamist's formulation is not affected by washing and does not transfer to partners, as well as being easily titratable between one, two or three sprays.