The FDA on Tuesday cleared
Sprout Pharmaceuticals' once-daily non-hormonal oral drug Addyi (flibanserin)
for generalised hypoactive sexual desire disorder (HSDD) in premenopausal
women, with the agency noting it is the first FDA-approved drug available to
treat sexual desire disorder in either men or women. The decision follows a
majority vote by an advisory panel in June recommending Addyi for approval.
The US regular stated that
Addyi is being approved with a boxed warning about the risks of severe
hypotension and syncope in patients who drink alcohol, in those who use
moderate or strong CYP3A4 inhibitors and in patients with liver impairment. The
therapy, which is a serotonin 1A receptor agonist and a serotonin 2A receptor
antagonist, is also being approved with a risk evaluation and mitigation
strategy, which includes elements to assure safe use, because of the increased
risk of severe hypotension and syncope due to the interaction with alcohol.
Prior to the FDA advisory panel vote, an agency staff report had questioned whether the drug's benefit
sufficiently outweighed its side effects.
In its decision, the FDA said
the effectiveness of Addyi was evaluated in three randomised Phase III trials
involving about 2400 premenopausal women with acquired generalised HSDD who
submitted self-reports of satisfying sexual events, sexual desire over the
preceding four weeks and distress related to low sexual desire. Results
indicated that compared to placebo, treatment with Addyi increased the number
of satisfying sexual events by 0.5 to 1 additional event per month, raised the
sexual desire score by 0.3 to 0.4, and decreased the distress score related to
sexual desire by 0.3 to 0.4.
Sprout refiled its application for Addyi earlier this year with
additional data after the FDA reaffirmed its decision to reject the drug in 2014. The
agency also refused to approve the therapy in 2010 after an advisory panel had unanimously votedagainst recommending clearance of the drug,
which at the time was being developed by Boehringer Ingelheim
Ref: CNN, The
Wall Street Journal, NBC News, TIME, ABC News, Financial Times, Bloomberg,
Washington Examiner, The New York Times, The Guardian, U.S. News & World,
CNBC, BBC News, Sprout Pharmaceuticals, Forbes, The Washington Post, FDA
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