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Vyleesi FDA Approval History

Reviewed by J.Stewart BPharm. Last updated on Jun 21, 2019.

FDA Approved: Yes (First approved June 21, 2019)
Brand name: Vyleesi
Generic name: bremelanotide
Dosage form: Injection
Company: AMAG Pharmaceuticals, Inc.
Treatment for: Hypoactive Sexual Desire Disorder

Vyleesi (bremelanotide) is a melanocortin receptor agonist for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.

  • Vyleesi is self-administered into a woman’s abdomen or thigh via prefilled autoinjector pen at least 45 minutes before anticipated sexual activity. It can be administered at any time of day.
  • Patients should not use more than one dose within 24 hours or more than eight doses per month.
  • In clinical trials, most patients used Vyleesi two or three times per month, and no more than once a week. In these trials, about 25% of patients treated with Vyleesi had an increase of 1.2 or more in their sexual desire score (scored on a range of 1.2 to 6.0, with higher scores indicating greater sexual desire) compared to about 17% of those who took placebo.
  • The most commonly reported adverse reactions (incidence >4%) include nausea (40%), flushing (20%), injection site reactions (13%), headache (11%), and vomiting (4.8%).
  • Vyleesi is the second female libido drug to gain FDA approval after Addyi (flibanserin) in 2015. Addyi originally carried a ban on alcohol consumption, which has since been eased. Vyleesi has no known alcohol restrictions.

Development Timeline for Vyleesi

DateArticle
Jun 21, 2019Approval AMAG Pharmaceuticals Announces FDA Approval of Vyleesi (bremelanotide injection) for Hypoactive Sexual Desire Disorder (HSDD) in Premenopausal Women
Jun  4, 2018Palatin Technologies Announces FDA Acceptance for Review of Bremelanotide NDA
Mar 26, 2018Palatin Technologies Announces Submission of Bremelanotide NDA to FDA for Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Premenopausal Women

Further information

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