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P&G's Intrinsa Priority Review Puts Approval Timeline At Early 2005

This article was originally published in The Pink Sheet Daily

Executive Summary

NDA for testosterone patch to treat reduced sexual desire in surgically menopausal women was submitted in early summer. First female sexual dysfunction agent filed at FDA is "next major opportunity" for P&G's pharmaceutical business, CFO Daley tells Banc of America Securities conference.

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Firm will conduct single 12-week trial for treatment of moderate to severe vasomotor symptoms with the transdermal estradiol spray. Evamist would be the first estradiol topical spray formulation, Vivus says.

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

Firm will conduct single 12-week trial for treatment of moderate to severe vasomotor symptoms with the transdermal estradiol spray. Evamist would be the first estradiol topical spray formulation, Vivus says.

P&G’s Intrinsa For Female Sexual Dysfunction To Get Cmte. Review Dec. 2

If recommended by FDA’s Reproductive Health Drugs Advisory Committee, Intrinsa would be on a path for approval in December or January. The testosterone patch could be the first treatment for female sexual dysfunction.

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