Sprout Pharmaceuticals has obtained approval from the US Food and Drug Administration (FDA) for its Addyi (flibanserin 100mg) to treat acquired, generalised hypoactive sexual desire disorder (HSDD) in premenopausal women.
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HSDD is a persistent absence of sexual thoughts, responsiveness and willingness to involve in sexual activity. While acquired HSDD pertains to HSDD that develops in a patient who previously had no problems with sexual desire.
Addyi is a once-daily and non-hormonal pill that is claimed to be the first and only FDA-approved treatment for HSDD, a common form of female sexual dysfunction.
Sprout Pharmaceuticals CEO Cindy Whitehead said: "We celebrate what this approval means for all women who have long awaited a medical treatment option for this life-impacting condition.
"We applaud the FDA for putting the patient voice at the centre of the conversation and for focusing on scientific evidence."
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Approval was based on three North American, Phase III, 24-week, randomised double blind and placebo-controlled studies of premenopausal women with HSDD.
The non-hormonal pill studies showed improvements in desire for sex, reduced distress from loss of libido and increased satisfaction, according to the company.
Flibanserin safety is based on clinical trial data in more than 8,500 women, with 1,000 of these exposed to treatment for at least one year
The firm administered Addy in around 2,500 premenopausal women with acquired, generalised HSDD in clinical trials, with 850 of them receiving treatment for at least 12 months.
Sprout is planning to make the pill commercially available for patients by October.
Image: FDA has approved Addyi to treat acquired, generalised hypoactive sexual desire disorder in premenopausal women. Photo: courtesy of Piyachok Thawornmat/ FreeDigitalPhotos.net.
