FDA Approves Medication to Treat Female Sexual Disorder

The Food and Drug Administration (FDA) on Fridayapproved Vyleesi (bremelanotide) to treat premenopausal women for acquired, generalized hypoactive sexual desire disorder (HSDD). HSDD (classified as female sexual interest/arousal disorder inDSM-5) is characterized by low sexual desire that causes distress and cannot be explained by a comorbid physical or psychiatric illness, the side effects of substance use or medications, or severe relationship problems. Acquired HSDD means a woman has previously experienced sexual desire (it has not been a lifelong problem).“There are women who, for no known reason, have reduced sexual desire that causes marked distress and who can benefit from safe and effective pharmacologic treatment,” said Hylton V. Joffe, M.D., M.M.Sc., director of the FDA’s Division of Bone, Reproductive, and Urologic Products in the agency press release. “As part of the FDA’s commitment to protect and advance the health of women, we’ll continue to support the development of safe and effective treatments for female sexual dysfunction.”The approval of Vyleesi was supported by two 24-week, randomized clinical studies involving 1,247 premenopausal women with HSDD. In both trials, Vyleesi was more effective than placebo at improving patient-reported sexual desire and reducing emotional distress. Vyleesi is not approved to enhance sexual performance, and women should not use more than one dose every 24 hours or more than eight doses per month, according to th...
Source: Psychiatr News - Category: Psychiatry Tags: blood pressure female sexual interest/arousal disorder hypoactive sexual desire disorder naltrexone premenopausal women sexual dysfunction Vyleesi Source Type: research