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| Courtesy: AMAG Pharmaceuticals |
The US Food
and Drug Administration (FDA) recently approved bremelanotide (Vyleesi, AMAG
Pharmaceuticals), for the treatment of hypoactive sexual desire disorder (HSDD)
in premenopausal women.
Vyleesi, a
melanocortin receptor agonist that comes as autoinjector, joins flibanserin(Addyi, Sprout Pharmaceuticals) as the class of drugs approved by the FDA for the
treatment of acquired HSDD. Flibanserin is Serotonin 5-HT-Receptor Agonists and
is taken orally.
HSDD is the
most commonly prevalent female sexual dysfunction and is largely
under-recognized and undertreated. It is believed that approximately 9% of all
premenopausal women in the United States experience it but less than half of these
patients seek help or initiate discussions with physicians.
“Women with HSDD often avoid situations that
could lead to intimacy, the impact of which goes far beyond the bedroom and can
often result in anxiety, loss of vitality, self-esteem issues and relationship
stress. It is important that women suffering from this condition have a choice
of treatment options available to them,” quote Anita H. Clayton, M.D., Chair,
Department of Psychiatry & Neurobehavioral Sciences, University of Virginia
School of Medicine, VA in an AMAG Pharma news release.
The upside
of bremelanotide is women need to use it as required as opposed to flibanserin
which must be consumed daily. The drug is
dispensed as prefilled autoinjector pen which has to be self-administered by the
woman into her abdomen or thigh at least 45 minutes before anticipated sexual
activity and can be taken at any time of day.
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Patients
should not use more than one dose within 24 hours or more than eight doses per
month. Patients should discontinue treatment after eight weeks if they do not
report an improvement in sexual desire and associated distress.
While the exact mechanism of action is still unknown, the drug is believed to act on the
melanocortin receptors in the central nervous system that are thought to be
associated with sexual function.
The FDA
approval of Vyleesi is based upon data from approximately 1,247 women in two
pivotal (NCT02333071 and NCT02338960), replicate, double-blind placebo-controlled Phase 3 trials (RECONNECT).
Most patients used the drug 2-3 times a month with no more than once a week.
Vyleesi does
not enhance sexual performance, but there was a statistically significant
increase in desire and decrease in distress at the time of intimacy. Women in both
the trials didn’t experience any problem with the autoinjector.
The most
common side effects of Vyleesi are nausea and vomiting, flushing, injection
site reactions, and headache. An increase in blood pressure was also noted,
which usually resolved in 12 hours. Hence, Vyleesi is contraindicated in
patients at high risk of cardiovascular disease and those with high-blood
pressure.
Vyleesi is
not indicated for the treatment of HSDD in postmenopausal women or in men. AMAG
is expected to make Vyleesi commercially available in September 2019 through
select specialty pharmacies.
