Wednesday, August 19, 2015

FDA Approves First Treatment for Hypoactive Sexual Desire Disorder in Women

Yesterday, the Food and Drug Administration approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The medication is the first FDA-approved treatment for sexual desire disorders in men or women.

“The problems associated with low sexual desire are commonly seen in psychiatric practice and may be comorbid with many psychiatric disorders, especially anxiety and mood disorders,” said Robert Segraves, Ph.D., M.S., a professor emeritus of psychiatry at Case Western Reserve University and a member of the Sexual and Gender Identity Disorders Work Group for DSM-5. “For the first time, an approved medication can be prescribed for this disorder.”

The approval of the Addyi—a serotonin 1A receptor agonist and serotonin 2A receptor antagonist—was based on data from three 24-week randomized, double-blind, placebo-controlled trials in approximately 2,400 premenopausal women with acquired, generalized HSDD. The average age of the trial participants was 36 years, with an average duration of HSDD of approximately five years. The participants took either an oral 100 mg dose of Addyi or placebo at bedtime.

Across the three trials, women taking Addyi were 10% more likely to report at follow-up meaningful improvements in past-month sexual event satisfaction or sexual desires than women being treated with placebo. On average, treatment with Addyi increased the number of satisfying sexual events by 0.5 to 1 additional event per month over placebo. The most common adverse reactions associated with the use of Addyi included dizziness, somnolence, and dry mouth. The mechanism by which Addyi improves sexual desires is currently unknown.

Addyi was approved also with a Boxed Warning to highlight the risk of severe hypotension and loss of consciousness (syncope) in patients who drink alcohol during treatment with Addyi and in those who use moderate to strong CYP3A4 inhibitors that interfere with the breakdown of the medication. The newly approved drug is also contraindicated for those with liver disease.

Because of the increased risk of severe hypotension and syncope due to the interaction between Addyi and alcohol, the FDA is requiring all prescribers of Addyi to enroll and complete training in a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use. Certified prescribers must counsel patients using a Patient-Provider Agreement Form about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol during treatment with Addyi. Only REMS-certified pharmacies will be allowed to dispense Addyi from a certified prescriber.

For more information on Addyi, see the FDA press announcement here. To read more about Sexual and Gender Identity Disorders, see the Psychiatric News article Layperson’s Guide to DSM-5 Describes Sexual Disorders, Gender Dysphoria.

(Image: Hurst Photo/


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