“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,” stated Cindy Whitehead, chief executive officer of Sprout, which grew out of Slate Pharmaceuticals in 2011. “We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence.”
A non-hormonal pill, Addyi is a once-daily treatment for premenopausal women with acquired, generalized HSDD — the most common form of female sexual dysfunction, affecting up to one in 10 women in the United States.
HSDD is defined as a persistent absence of sexual thoughts, fantasies, responsiveness and willingness to engage in sexual activity that causes personal or relationship distress and can’t be explained by another medical condition or substance. Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire, while generalized HSDD denotes that the condition occurs regardless of the type of stimulation, situation or partner.
According to Sprout, flibanserin has been studied in more than 11,000 women, and the FDA approval of Addyi is largely based on three North American, Phase 3, 24-week, randomized double-blind, placebo-controlled studies of premenopausal women with HSDD. For premenopausal women with HSDD, Addyi has demonstrated improvements in desire for sex, reducing distress from the loss of sexual desire and increasing the number of satisfying sexual events, the company said.
Sprout noted that Addyi isn’t indicated for the treatment of HSDD in postmenopausal women or in men, and the drug isn’t indicated to enhance sexual performance.
The FDA reported Tuesday that, prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” commented Janet Woodcock, 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.”
Woodcock added, “Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies. Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”