21 June 2019 - The U.S. FDA today approved Vyleesi (bremelanotide) to treat acquired, generalised hypoactive sexual desire disorder in pre-menopausal women.

Hypoactive sexual desire disorder (HSSD) is characterised by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship or the effects of a medication or other drug substance. Acquired HSDD develops in a patient who previously experienced no problems with sexual desire. Generalised HSDD refers to HSDD that occurs regardless of the type of sexual activity, situation or partner.

The effectiveness and safety of Vyleesi were studied in two 24-week, randomised, double-blind, placebo-controlled trials in 1,247 premenopausal women with acquired, generalised HSDD.

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