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Vyleesi 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 History and FDA Approval Process for Vyleesi

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
Aug  4, 2016Palatin Technologies Announces Completion of All Patient Visits In Phase 3 Clinical Trials of Bremelanotide for Hypoactive Sexual Desire Disorder
Dec 29, 2014Palatin Announces Start of Bremelanotide Phase 3 Program For Female Sexual Dysfunction
Mar  1, 2013Palatin Technologies Presents Positive Data for Bremelanotide in Female Sexual Dysfunction
Aug 17, 2010Palatin Technologies, Inc. Announces Positive Safety Results in Subcutaneous Bremelanotide Trial in Men
Aug 12, 2009Palatin Technologies, Inc. Reports Positive Bremelanotide Study; Improved Safety Profile with Subcutaneous Administration
Sep 27, 2007Palatin Technologies, Inc. Reports Positive Data from an At-home Study of Pre- and Postmenopausal Women with Female Sexual Arousal Disorder Treated with Bremelanotide
May 23, 2007Palatin Technologies and King Pharmaceuticals Report Data Showing Improvements in Sexual Relationship and Self-Esteem in Patients with Erectile Dysfunction Treated with Bremelanotide
May  9, 2007Palatin Technologies and King Pharmaceuticals Announce Plan To Present Results of Bremelanotide Phase 2b Studies in Men With Erectile Dysfunction
Feb 26, 2007Palatin Technologies and King Pharmaceuticals Announce Presentation Regarding Clinical Study Evaluating Bremelanotide in Post-Menopausal Female Sexual Dysfunction Patients

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.