Vivus' Phase III program for the topical estradiol spray Evamist has been cleared under an FDA special protocol assessment, the firm said Dec. 16.

Evamist is a metered dose transdermal spray formulation of the menopause therapy.

Vivus will conduct a single 12-week Phase III double-blind, placebo-controlled trial with the primary endpoint of reduction in moderate to severe vasomotor symptoms at week 4 and week 12. FDA requires only a single trial to support NDAs for estradiol products, the company said.

Evamist uses Vivus' MDTS delivery technology, which the company describes as a "simple to use spray that is... placed gently against the skin and depressed releasing a light spray, which quickly dries on the skin."

"Estradiol is released into the blood stream on a sustained basis over 24 hours, providing a practical and convenient once-a-day dosing regimen."

Evamist would be the first formulation of its kind, according to Vivus. However, estradiol is already available in tablet, topical emulsion/gel, transdermal patch/film and intravaginal ring formulations.

Vivus is also developing a testosterone spray for treatment of low sexual desire in women which could enter Phase III in 2005. Vivus' topical formulation of alprostadil, Alista , is currently in Phase III trials for female sexual dysfunction (¹ Also see "P&G's Intrinsa Priority Review Puts Approval Timeline At Early 2005" - Pink Sheet, 21 September, 2004.).

- Lee Szilagyi

Vivus Evamist Menopause Spray To Start Phase III Under Special Protocol Assessment

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