Recently approved by the FDA, Vyleesi™ (bremelanotide) provides another dimension in the treatment of hypoactive sexual desire disorder (HSDD), one of the most notable conditions affecting pre-menopausal women.
Vyleesi was developed by Palatin Technologies under the trade name Rekynda™ (bremelanotide). The company licensed the drug to AMAG Pharmaceuticals for development and marketing in North America under the brand name Vyleesi, in February 2017.
The new drug was submitted to the FDA for approval in March 2018. After a 12+ month review process, the FDA granted approval to the drug in June 2019. This approval made Vyleesi the first drug to be approved for the purpose of treating acquired or generalised HSDD affecting pre-menopausal women. Other solutions such as Addyi were introduced before to treat loss of sexual desire in women.
Expect more developments and buzz to surround this drug as pharmaceutical companies are promoting it in China, South Korea, and many other markets.
Based on positive results and testing, Vyleesi earned approval after a series of clinical trials in which up to 1,200 women with HSDD reported their responses.
During the first phase, tested women were involved a 24-week placebo-controlled study. During the second phase, women were extensively studied for up to 52 weeks.
The co-primary conclusions of the studies were an improvement in sexual desire and reduction in distress related to sexual dysfunction as defined by standard indexes.
More information about Vyleesi’s recent approval can be found at https://www.drugdevelopment-technology.com/projects/vyleesi-bremelanotide/