FDA approves 'pink Viagra,' first drug to improve libido for women

For the first time, the U.S. Food and Drug Administration has given its blessing to a prescription drug intended to increase sexual desire in women.
The FDA’s green light on the drug flibanserin, often known by the nickname "pink Viagra," reverses two earlier decisions to reject the medication as a treatment for hypoactive sexual desire disorder, or HSDD.
The decision, announced late Tuesday, comes in the wake of a public campaign that has challenged the agency to close a widening gap between the numbers of medications available for men’s sexual health and those available to women.


“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “We are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”
The drug is the first FDA-approved treatment for sexual desire disorders in either women or men, according to the agency.
Flibanserin, which will be marketed as Addyi, is a once-a-day pill for women who are distressed by their low sex drive. Women are not considered to have HSDD if their drop in sexual desire is due to another medical or psychiatric condition, a side effect of medication or a problem in their relationship.
Clinical trial data presented to the FDA showed that compared with study participants who got a sham medication, pre-menopausal women who took flibanserin reported a modest but measurable rise in sexual desire and increased the number of “sexually satisfying encounters” they had by roughly one per month.
In tests, the most common side effects of the drug included dizziness, sleepiness, nausea, fatigue and insomnia, the FDA said. Addyi is to be taken at bedtime to reduce these risks, according to the agency.
The drug appears to influence a neurotransmitter called serotonin, as do some types of antidepressants. However, the mechanism by which Addyi improves sexual desire is not understood.

Sprout Pharmaceuticals, a Raleigh, N.C., startup that in 2010 purchased the rights to sponsor flibanserin’s FDA application, said it expected to make Addyi available to patients starting in mid-October. It is expected that gynecologists will be the main prescribers, but it could also be prescribed by primary care physicians and mental health professionals who specialize in sexual health.
The FDA will require a boxed warning to highlight these risks.

 I'm sure this is considered as  amaze-balls news, i can already hear people popping their champagnes.

Oh before i forget...
Source: L.A. Times