The FDA said on Friday that it has approved Vyleesi, a drug for women with low libido. The drug bremelanotide, sold under the brand name, Vyleesi by AMAG Pharmaceuticals is an injection that will be taken before sex.
It’s intended to treat premenopausal women and hypoactive sexual desire disorder in women, where low libido can cause significant distress in women.
AMAG Pharmaceuticals spokeswoman, Sarah Connors said the drug will hit the market in September, but the company is yet to determine pricing and reimbursement information.
Sheryl Kingsberg, a clinical psychologist and divisional chief of Behavioural Medicine at the University Hospitals, Cleveland Medical Center, who was involved in the drug’s clinical trials, said, “Most women who come into my office have no idea that there’s this condition——-and that they are one of millions,” and that “the impact of sexual dysfunction on a woman’s self-esteem, on her body image, on her self-confidence and on her relationship is profound.”
Dr. Julie Krop, Chief Medical Officer of AMAG Pharmaceuticals said of Vyleesi, “Based on our data, we don’t have an interaction with alcohol, so we don’t believe there will be restrictions.”
Older drugs like Flibanserin, which was sold as Addyi, are not widely used because women couldn’t take it with alcohol and health providers had to be specially certified to prescribe it.
The most common side effects of Vyleesi are headache, nausea and flushing. Kingsberg said women who experienced nausea during the drug trials, largely kept on using the drug and for them, “the benefit outweighed the tolerability issue.”
Culled from CNN