The drug is a non-hormonal agent that acts on neurotransmitters in the brain, and aims to treat HSDD among women who have not yet entered menopause.
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The FDA specifically approved the drug for premenopausal women with hypoactive sexual desire disorder, a lack of sexual appetite that causes distress. Women who took the drug in a clinical study had an increase of about 1.0 sexually satisfying event (SSE) per month compared with those taking a placebo. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment”.
The drug can thus cause a significant drop in blood pressure and fainting. Women should also avoid taking Addyi with certain other drugs, including some medications used to treat yeast infections. The nurses at Stanford’s Gynecology Clinic have been busy fielding calls from patients wanting to know about what some are calling female Viagra.
Other common side effects include dizziness, nausea, fatigue, insomnia and dry mouth. Additionally, pharmacies must be certified with the REMS program by enrolling and completing training. The once-daily treatment, which will be known commercially as Addyi, is intended to improve sexual desire among premenopausal women. The German company changed gears and pursued FDA approval for the drug as a treatment for hypoactive sexual desire disorder in 2010.
“It’s beyond ridiculous that this is being called “female” Viagra, ‘” Bat Sheva Marcus, a sexual-dysfunction specialist at the Medical Center for Female Sexuality in New York, told Business Insider.
The drug, which carries the brand name “Addyi”, was developed by Raleigh-based Sprout Pharmaceuticals and is the third time the company has applied for approval from FDA. “Turning low libido around, without having a biological component to your treatment like a flibanserin, is difficult”, she said. “We’re concerned that drug companies are trying to sell hope and hype”, Breast Cancer Member Karuna Jaggar said. That led to charges that the FDA was being sexist by making the drug jump through more hoops than Viagra and other drugs for male sexual problems.
The diagnosis is not universally accepted and many psychologists argue that low sex drive should not be considered a medical condition.
Addyi will ship with a boxed warning detailing the drug’s risks of severe low blood pressure and fainting spells, side effects that are exacerbated by alcohol use, according to the FDA.
The pursuit of a drug for women with low libido has been like a Holy Grail for the pharmaceutical industry, given the enormous popularity and financial windfall from the erectile dysfunction drugs Viagra and Cialis for men since the late 1990s.
Sprout is staying tight-lipped on its sales projections for the product – and as yet there is no word on pricing – but there does seem to be a core of women anticipating Addyi’s US launch, which is set for October.
WHITEHEAD: For decades, millions of women have been waiting for a medical solution to restore their sexual desire.
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The Food and Drug Administration has approved the first drug designed to boost a woman’s libido.
