Pink Viagra finally gets to First Base

This is a big moment in women’s health. In early June, an FDA advisory committee recommended approval of flibanserin, which will become the first drug approved to specifically boost female sexual desire. A formal and final decision by the FDA is expected later this summer, but they usually follow the advice of their advisory committees.

Mary Heim R.Ph. FAAFM Women's Health Specialist

Mary Heim R.Ph. FAAFM
Women’s Health Specialist

Flibanserin has been rejected twice by the FDA prior to this victory. Flibanserin, manufactured by Sprout Pharmaceuticals, is a 100mg once daily oral tablet for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. In other words, the medication addresses low libido or decreased sexual desire. The medication shows modest but statistically significant improvement in patients with HSDD. It does exhibit a very large placebo effect and there are concerns about concurrent use with alcohol. Dizziness and drowsiness increased when flibanserin was combined with alcohol and escalated with higher doses of alcohol.

Some speakers at the FDA public hearing accused the agency of gender bias, noting that many sexual dysfunction drugs had been approved for men in the past, despite safety and efficacy concerns. Representatives of the FDA rejected this claim and stated the FDA considered HSDD an unmet medical need.  Currently some physicians will prescribe compounded low dose topical testosterone creams to treat HSDD in women. In 2004, the FDA rejected an experimental testosterone patch for women to treat HSDD due to long-term safety concerns. Hopefully, a company with Sprout Pharmaceutical’s persistence will actively seek approval for female topical testosterone.

by Mary Heim, RPh, FAAFM

Mark your calendars for Tuesday, July 21st at 5:00pm. The subject of our Hormone Happy Hour that evening will be “Female Sexual Function and Dysfunction” with special guest Nisha McKenzie PA-C. 

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7 Responses to Pink Viagra finally gets to First Base

  1. Laurie Wellman says:

    Am planning on attending this seminar

  2. luann holzwarth says:

    I will try to make the seminar on Tuesday 7/21.
    About where on Cascade Rd. are you?

    Thank You
    Luann

  3. Linda Taylor says:

    GREAT idea for a program. Looking forward to it!

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