Vivus submitted a new drug application for EvaMist , its therapy for vasomotor symptoms (hot flashes) associated with menopause, on Sept. 29, the company told "The Pink Sheet" DAILY.

The estimated user fee date for the metered-dose, transdermal estradiol spray is July 29, 2007. Mountain View, Calif.-based Vivus will move "as aggressively as possible" to make the product available once approved, the company said.

The "small, hand-held" spray "may offer significant advantages over oral, gel and patch hormone replacement products," the company said. Because it is a transdermal product, the company feels that EvaMist has a much better safety profile than oral estrogen products, Vivus told "The Pink Sheet" DAILY.

The company announced positive Phase III results in May (¹ Also see "Vivus Could File Evamist Menopause Spray By Year-End" - Pink Sheet, 5 May, 2006.). In the study, "the reduction in frequency and severity of moderate to severe hot flashes was statistically significant over placebo for all three doses," the company reported. Additionally, "application site irritation was 1.5% and was typically mild."

EvaMist uses Vivus' MDTS deliver technology, which is "designed to provide an easy and convenient means to deliver a preset dose of estradiol via the skin," the company said. Depending on the dose required, the product can be administered in one, two or three sprays.

-Shirley Haley (s.haley@elsevier.com)

Vivus Submits NDA For Skin Spray To Treat Hot Flashs

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