Sex Desire Drug Rejected by FDA

Holy Hormones Journal: First – sex researchers determine that women’s sexual desires have been repressed – that we are actually ravenous, sex desire druganimalistic base creatures.  Then the drug companies come out with a drug to increase our sexual desires. And they label it as ‘hypoactive sexual desire disorder’. Sigh.

Not only that, the drug maker appealed the decision. No surprise that they are the ‘first’ #1, to develop a drug for this ‘disorder.’ Women beware. do not be another medical experiment.  There were many women’s health advocates who worked hard to get this drug denied by the FDA.

Female Sexual Desire Drug Rejected by U.S. Regulators

Bloomberg
By Anna Edney Dec 11, 2013 6:27 AM MT

Flibanserin, if approved, would treat a sexual disorder known as female hypoactive sexual desire disorder, which is low libido that causes stress, according to Sprout. The drug is indicated for use by women who haven’t yet gone through menopause.

A pill to treat low sexual desire in women was rejected by U.S. regulators, a decision that has been appealed by the drug’s maker in a bid to make it the first product for the disorder.

The U.S. Food and Drug Administration based its decision to turn down the medicine on what the agency called a modest effect, closely held Sprout Pharmaceuticals Inc. said today in a statement. Sprout, based in Raleigh, North Carolina, is seeking approval of the therapy, known as flibanserin, as an option for women whose low libido causes stress in their lives.

In clinical trials, Sprout’s pill almost doubled the increase women saw in satisfying sexual experiences over a month’s time compared with patients who took a placebo, the company said. The agency’s decision contrasts with its review of drugs to treat male sexual dysfunction, Cindy Whitehead, president and chief operating officer at Sprout, said in an interview. The agency on Dec. 6 issued its 24th approval of a treatment for male sexual dysfunction, an injection called Xiaflex to treat a condition that causes a curved penis.

“I do believe that women deserve a solution to their most common form of sexual dysfunction,” Whitehead said. “Flibanserin has been in 11,000 patients at this point. It’s pretty well defined.”

The FDA accepted Sprout’s appeal on Dec. 3 after turning down the drug about two months ago. Because Sprout isn’t publicly traded, the company didn’t make public when the pill was rejected.

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.