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, 2019|| AMAG Pharmaceuticals Announces FDA Approval of Vyleesi (bremelanotide injection) for Hypoactive Sexual Desire Disorder (HSDD) in Premenopausal Women|
|Jun 4, 2018||Palatin Technologies Announces FDA Acceptance for Review of Bremelanotide NDA|
|Mar 26, 2018||Palatin Technologies Announces Submission of Bremelanotide NDA to FDA for Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Premenopausal Women|
|Aug 4, 2016||Palatin Technologies Announces Completion of All Patient Visits In Phase 3 Clinical Trials of Bremelanotide for Hypoactive Sexual Desire Disorder|
|Dec 29, 2014||Palatin Announces Start of Bremelanotide Phase 3 Program For Female Sexual Dysfunction|
|Mar 1, 2013||Palatin Technologies Presents Positive Data for Bremelanotide in Female Sexual Dysfunction|
|Aug 17, 2010||Palatin Technologies, Inc. Announces Positive Safety Results in Subcutaneous Bremelanotide Trial in Men|
|Aug 12, 2009||Palatin Technologies, Inc. Reports Positive Bremelanotide Study; Improved Safety Profile with Subcutaneous Administration|
|Sep 27, 2007||Palatin 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, 2007||Palatin Technologies and King Pharmaceuticals Report Data Showing Improvements in Sexual Relationship and Self-Esteem in Patients with Erectile Dysfunction Treated with Bremelanotide|
|May 9, 2007||Palatin Technologies and King Pharmaceuticals Announce Plan To Present Results of Bremelanotide Phase 2b Studies in Men With Erectile Dysfunction|
|Feb 26, 2007||Palatin Technologies and King Pharmaceuticals Announce Presentation Regarding Clinical Study Evaluating Bremelanotide in Post-Menopausal Female Sexual Dysfunction Patients|
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