Vyleesi Approved for Hypoactive Sexual Desire Disorder
June 21, 2019 – The U.S. FDA has approved Vyleesi™ (bremelanotide injection), manufactured by Palatin Technologies, to treat premenopausal women who have acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty that is not due to:
- A co-existing medical or psychiatric condition
- Problems with a relationship
- The effects of a medication or drug substance
HSDD is a sexual dysfunction in which the patient experiences low sexual desire that causes marked distress and/or interpersonal difficulty. According to the FDA, “acquired HSDD develops in a patient who previously experienced no problems with sexual desire,” and generalized HSDD “occurs regardless of the type of sexual activity, situation, or partner.”
In clinical trials, 25% of patients treated with Vyleesi had an increase of 1.2 points or more in their sexual desire score (scored on a range of 1.2 to 6.0), compared to approximately 17% of patients who received a placebo. In addition, 35% of patients treated with Vyleesi had a decrease in their distress score (rated on a scale of zero to four) of one or more, compared to approximately 31% of patients who received the placebo. Vyleesi does not enhance sexual performance, but is believed to improve sexual desire by activating melanocortin receptors.
Recommended dosing is 1.75mg via subcutaneous (SC) injection as needed, self-administered in the abdomen or thigh using an autoinjector at least 45 minutes prior to anticipated sexual activity. Patients should not use more than one dose within 24 hours, or more than eight doses per month. Treatment should be discontinued after eight weeks if there has been no improvement in sexual desire and associated distress.
Vyleesi is expected to launch in September 2019. Pricing plans have not yet been announced.