Last Friday, the FDA approved a new drug that some are referring to as “the female Viagra.” Vyleesi, the drug’s market name, is injectable bremelanotide intended to restore natural sexual desire in premenopausal women suffering from hypoactive sexual desire disorder (HSDD). Vyleesi is the second FDA-approved treatment for female HSDD. Addyi, the other drug approved for HSDD in 2015, is a pill that must be taken daily and restricts alcohol use, whereas Vyleesi is administered as needed and does not restrict alcohol use.
According to AMAG Pharmaceuticals, the U.S. sponsor of the drug, approximately six million premenopausal women in the United States suffer from HSDD. The FDA defines HSDD as “low sexual desire that causes marked distress or interpersonal difficulty.” Underlying medical or psychiatric conditions, relationship problems, or other drug substances do not cause HSDD. In a statement from the FDA, Dr. Hylton V. Joffe—director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive, and Urologic products—stated “there are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment.”
Vyleesi operates by activating melanocortin receptors, a brain-stimulating hormone associated with sexual arousal in both men and women. The medication is injected under abdomen or thigh skin 45-minutes before sexual activity. Patients are instructed only to use one dose within 24 hours, and no more than eight doses per month.
Two 24-week safety and effectiveness trials included 1,247 premenopausal women with generalized HSDD. Common side effects of Vyleesi are nausea and vomiting, flushing, injection site reactions, and headache. In clinical trials, approximately 40% of participants experienced nausea. Because Vyleesi increases blood pressure after injecting, patients with high blood pressure or cardiovascular disease are warned not to use the drug.
AMAG Pharmaceuticals estimates that Vyleesi will be available in September through select pharmacies. Prior to the FDA’s approval, AMAG launched a campaign to increase awareness and end stigma about female HSDD. The key message of this campaign—called “unblush”—is that “HSDD can be caused by an imbalance of certain hormones and neurotransmitters in the brain, a surmise drawn from functional MRI scans of women with varying levels of sexual desire. If the basis of the condition is physiological, so too may be the fix.”
Sources: FDA, AMAG, LA Times, Photo via AP News
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