FDA approves Addyi, Sprout’s ‘female Viagra’

SILVER SPRING, Md. — The Food and Drug Administration handed down its anticipated approval of Sprout Pharmaceuticals’ Addyi (filbanserin 100 mg), a treatment for women with generalized hypoactive sexual desire disorder. The approval is the first for any drug addressing  sexual desire disorders, and the first HSDD, the most common form of female sexual dysfunction. 

 

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

 

 

HSDD is characterized by persistent lack of sexual thoughts and responsiveness, as well as an unwillingness to engage in sexual activity that causes distress and can’t be explained by other conditions or substances

 

Addyi was approved with a Rish Evaluation and Mitigation Strategy (REMS) program, which will require certification for both pharmacists and providers. The drug is expected to hit the market on Oct. 17. 

 

“It has been a remarkable journey to get to this breakthrough moment. Today we celebrate what this approval means for all women who have long awaited a medical treatment option for this life impacting condition,” Sprout CEO Cindy Whitehead said. “We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence.”