FDA approves ‘female viagra’
pharmafile | August 19, 2015 | News story | Research and Development, Sales and Marketing | Addyi, FDA, HSDD, Sprout, Sprout Pharmaceuticals, flibanserin, hypoactive sexual desire disorder
The FDA has approved Sprout Pharmaceuticals’ Addyi, a controversial libido-enhancing drug for women that has been dubbed the ‘female viagra’.
Addyi (flibanserin), which is taken once-nightly, treats acquired, generalised hypoactive sexual desire disorder (HSDD) in premenopausal women by boosting serotonin levels in the brain.
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 cannot be accounted for by another medical condition or substance.
Addyi was initially developed by Boehringer Ingelheim, which sold it to North Carolina-based start-up Sprout after the FDA rejected the initial version of the drug in 2010.
The effectiveness of the 100 mg bedtime dose of Sprout’s Addyi was evaluated in three 24-week randomised, double-blind, placebo-controlled trials in about 2,400 premenopausal HSDD sufferers, averaging 36 years of age.
Positive results were somewhat marginal, with patients in the trial reporting a slight increase in sexual desire and a slight decrease in distress relating to lack of desire. About 10% more Addyi-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress. This 10% reported an average of 0.5 more ‘sexually satisfying’ events per month.
But Addyi’s approval came with warnings from the FDA over side effects that could discourage practitioners from prescribing the drug, including dizziness, somnolence, nausea, fatigue, insomnia and dry mouth.
More seriously, Addyi users who drink alcohol risk severe hypotension (low blood pressure) and syncope (fainting caused by low blood pressure). These side effects caused the FDA to reject the drug in 2010 and again in 2013, when Sprout resubmitted it with additional effectiveness and safety data.
Despite the conditions, Cindy Whitehead, chief executive of Sprout, celebrated the fact that the FDA had finally approved the treatment. Women’s sexual health equity groups, including ‘Even the Score’ – backed financially by Sprout and others – had bemoaned the fact that while there are currently 26 FDA-approved treatments for various male sexual dysfunctions, there were none for HSDD, the most common women’s sexual dysfunction.
“It has been a remarkable journey to get to this breakthrough moment,” Whitehead says. “Today 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.” Addyi is expected to be available by October 17, 2015.
Joel Levy
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