FDA approves ‘female Viagra’

FDA approves ‘female Viagra’
Credit: Associated Press

The FDA has approved AMAG Pharmaceutical Vyleesi (bremelanotide) to treat acquired, generalised hypoactive sexual desire disorder (HSDD) in premenopausal women.

HSDD 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.

Vyleesi activates melanocortin receptors, but the mechanism by which it improves sexual desire and related distress is unknown.

Patients inject Vyleesi under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity and may decide the optimal time to use Vyleesi based on how they experience the duration of benefit and any side effects, such as nausea.

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.

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 compared to about 17% of those who took placebo.

Additionally, about 35% of the patients treated with Vyleesi had a decrease of one or more in their distress score compared to about 31% of those who took placebo.

There was no difference between treatment groups in the change from the start of the study to end of the study in the number of satisfying sexual events.

In 2012, the FDA identified female sexual dysfunction as one of 20 disease areas of high priority and focused attention.