Flibanserin for Low Desire Has Been FDA-Approved for Premenopausal Women

By on August 19th, 2015 Categories: Sex Matters

On August 18, 2015, the U.S. Food and Drug Administration (FDA) approved flibanserin: the first and only medication for the treatment of distressing low desire or Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women.

What is HSDD?

Hypoactive Sexual Desire Disorder (HSDD) is a medical condition recognized since 1977. It’s the most common form of female sexual dysfunction. HSDD is defined as the persistent loss of desire for sex that is causing personal or relationship distress and cannot be accounted for by another medical condition or substance.

What is not HSDD?

HSDD is NOT lack of interest in sex because of a partner issue. Counseling may be right for that situation — not medication. Low desire because of no time, energy, or privacy is also NOT HSDD. If you have desire on vacation in Hawaii but not home in Chicago, you do not have HSDD. Levels of desire normally go up and down over time.

Fast facts about flibanserin

  • The brand name for flibanserin is Addyi (pronounced add-ee).
  • Addyi is a once-daily, non-hormonal pill that is taken at bedtime.
  • Addyi is believed to work on three key chemicals in the brain involved in the sexual desire response, restoring and modulating balance to excitatory and inhibitory factors for women with Hypoactive Sexual Desire Disorder (HSDD).
  • Addyi has been studied in clinical trials of over 11,000 women and has shown the following benefits:
    • increases in sexual desire by 53% (measured by the Female Sexual Function Index)
    • decreases in distress by 29% (measured by the Female Sexual Distress Scale)
    • double the number of satisfying sexual events (SSEs)
  • For a long time, men have had many FDA-approved treatments for low libido. Finally, there is an option for women. Women in the trials themselves report the effects of Addyi to be meaningful to them.
  • Addyi’s most common side effects are dizziness, nausea, and sleepiness.
  • Addyi has interactions with other substances that affect the central nervous system (including alcohol) as well as antifungals.
  • Addyi will not work for all women with HSDD. But across clinical trials it worked meaningfully for 46-60% of women within 6 months — restoring their sexual desire to within normal ranges.
  • As of date of approval, flibanserin has not yet been adequately studied in the breast cancer population.
  • Discuss your symptoms with your healthcare professional, and together you both can decide if Addyi is right for you.

It’s a monumental day! There’s finally a safe, effective treatment for women with distressing lowered sexual interest!

Michael L. Krychman, M.D.C.M., is the executive director of the Southern California Center for Sexual Health and Survivorship Medicine in Newport Beach, California. He is the former co-director of the Sexual Medicine and Rehabilitation Program at Memorial Sloan-Kettering Cancer. Dr. Krychman is also an American Association of Sexuality Educators, Counselors and Therapists (AASECT) certified sexual counselor. He is an associate clinical professor at the University of California, Irvine, Division of Gynecological Oncology, and the medical director of Ann’s Clinic, a high-risk program for breast and ovarian cancer survivors. His special interests include menopausal health, hormone therapy, sexual pain disorders, loss of libido, and chronic medical illness and its impact on female sexual function as well as breast cancer sexuality. Dr. Krychman is also a member of the Breastcancer.org Professional Advisory Board.

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