RALEIGH – Sprout Pharmaceuticals says data from three clinical trials proves the efficacy of its female sexual disfunction drug Addyi – often called the “female Viagra.”

Sprout tangled with the US Food and Drug Administration last fall after Sprout issued a press release over the possibility of less restrictive labeling for use of Addyi with alcohol. That release was removed from the Sprout website.

This time, Sprout is touting evidence that it says “demonstrates significant improvements in female sexual disfunction for arousal, desire, lubrication, satisfaction and orgasm.”

“These findings paint a much fuller picture of the treatment outcomes patients may experience with Addyi. Addressing the desire issues of HSDD can cascade to better arousal, lubrication and orgasms,” said James Simon, an MD and former chief medical officer at Sprout. He is currently Clinical Professor at George Washington University and president of IntimMedicine Specialists. “It’s no surprise that these aspects of the sexual experience can be interrelated so improving one can improve the others.”

The new data was presented at the International Society for the Study of Women’s Sexual Health Annual Meeting in Orlando, Fla.

“With the next frontier of wellness being sexual wellness, we stand proud in leading the charge for evidence-based solutions to address women’s common sexual struggles,” said Cindy Eckert, Sprout’s CEO, in the announcement of the data.

“These findings continue to excite us about Addyi’s significance in addressing a common need for women and pioneering a new category to serve them.”

Sprout cited three “randomized, placebo-controlled trials assessing efficacy of Addyi in treating premenopausal women with Hypoactive Sexual Desire Disorder, or HSDD.”

The tests “show clear benefits in multiple areas of female sexual function in as early as 4 weeks and maintained for duration of treatment,” Sprout added.

Findings were based on the “Female Sexual Function Index (FSFI) which measures female sexual function in six distinct areas,” Sprout added.

Sprout points out that Addyi is “the first and only FDA-approved non-hormonal pill for acquired, generalized hypoactive (low) sexual desire disorder for premenopausal women.”

Sprout is based in Raleigh.

Sprout CEO: Next step in dispute over female sexual dysfunction drug is up to FDA