Vyleesi FDA Approval History
Last updated by Judith Stewart, BPharm on July 8, 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
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