FDA approves new drug for women with low sexual desire disorder
Posted on June 24, 2019
The US Food and Drug Administration approved a drug to return sexual desire to some women with low libido, the agency said Friday.
The drug, bremelanotide, sold under the brand name Vyleesi by AMAG Pharmaceuticals, is an injection to be taken before sex. It's intended to treat women who are premenopausal and have hypoactive sexual desire disorder, where a lack of interest in sex may cause significant distress in a woman's life.
It will be available in September, and the company has not yet determined pricing or reimbursement information, according to AMAG spokeswoman Sarah Connors.
Experts say the diagnosis is the most common type of sexual dysfunction among women, estimated to affect between 8% to 10% of women.
Not the first drug for women's sexual desire
Bremelanotide is not the first drug to be approved for this purpose. The drug flibanserin, sold as Addyi by Sprout Pharmaceuticals, was approved in August 2015. However, in the wake of both fanfare and controversy, the drug has not been not widely used, in part because women couldn't take it with alcohol and health care providers had to be specially certified to prescribe it.
Another difference between the drugs is that Addyi, an oral tablet, is taken once daily, whereas patients can take bremelanotide as needed.
New drug's side effects
The most common side effects of Vyleesi are nausea, headache and flushing.