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Bremelanotide (brand name Vyleesi™) is approved by the FDA for treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
The full wording of the FDA indication is as follows (emphasis added):
“VYLEESI is a melanocortin receptor agonist indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:
– A co-existing medical or psychiatric condition,
– Problems with the relationship, or
– The effects of a medication or drug substance.”
The Prescribing Information also notes:
“Limitations of Use:
– Not indicated for treatment of HSDD in postmenopausal women or in men.
– Not indicated to enhance sexual performance.”
Note that the FDA indication is for “hypoactive sexual desire disorder (HSDD)” that is “acquired” and “generalized.” Let’s clarify what these terms mean.
What is hypoactive sexual desire disorder (HSDD)?
HSDD is a DSM-IV diagnosis (now subsumed in DSM-5 under “Female Sexual Interest/ Arousal Disorder“) that is characterized by low sexual desire that is associated with marked distress and interpersonal problems and NOT associated with a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other substance.
What is “acquired” HSDD?
The FDA-approved Prescribing Information says that “Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire.” This is not correct as stated. Actually, it is not that the woman can never have had problems with sexual desire in the past. “Acquired” means that the problem has not been lifelong, that is, present since the woman became sexually active. Instead, the woman had at least some period of time during which she had relatively normal desire and THEN she developed this low desire.
What is “generalized” HSDD?
Generalized HSDD is HSDD that occurs irrespective of the type of sexual activity, situation, or partner.
Dosage and Administration
Bremelanotide can be self-administered by injecting under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity.
Patients should not administer bremelanotide more than once per 24 hours or more than eight times per month. If no improvement in sexual desire is experienced after 8 weeks of treatment, patients should discontinue treatment.
Potential side effects
Nausea and vomiting, flushing, injection site reactions, and headache are the most common side effects associated with bremelanotide. Nausea was reported by about 40% of patients and 13% needed medications for the treatment of nausea.
Other side effects include darkening of the gums and part of the skin, especially in patients with dark skin, and increase in blood pressure after dosing which usually resolves in 12 hours.
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