In a press release Dr. Hylton V. Joffe of the FDA said, “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 will be available to premenopausal women with hypoactive sexual desire disorder that is characterized by chronically low or nonexistent sexual desire which can often cause distress. Hypoactive sexual desire disorder is not often spoken about, but as many as 10% of women, it can affect women of all ages, and it is not clearly understood why it happens. Currently there are no approved medications for menopausal women suffering with hypoactive sexual desire disorder.
According to Dr. Sharon Parish of Weill Cornell Medical College, “Clinicians don’t have a process for diagnosing and addressing it. It’s under-recognized.”
Vyleesi is not the only medication aimed at improving a woman’s sex life, Addyi was approved in 2015. However, Addyi was recently FDA safety mandated to be labeled with a warning after reports of concerning side effects which includes severely low blood pressure and fainting, especially when used with alcohol.
Vyleesi is a safer alternative, and is an injection drug meant to be used 25-40 minutes before intercource which lasts up to 8 hours and showed statistically significant increases in sexual desire among the women who used it during phase 3 clinical trials; it works by stimulating certain receptors in the brain believed to be integral to sexual functioning. Vyleesi does come with some side effects: people with uncontrolled blood pressure should not take it; and some women may experience nausea, headache, and a mild increase in blood pressure.
Vyleesi may be an injectable, but its makers say it shouldn’t be a concern because the needle is tiny and it comes as an injectable pen. “In our trials, nobody stopped using Vyleesi because it was injectable,” says Dr. Carl Spana.
With FDA approval Vyleesi is now set to hit the market this September, no pricing information is currently available.
