FDA approves first treatment for sexual desire disorder

[Nelson Vergel]

The U.S. Food and Drug Administration today approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.
“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Wood****, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”
HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner.
“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” continued Dr. Wood****. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”
http://www.fda.gov/NewsEvents/Newsr...livery&utm_medium=email&utm_source=govdeliver

 

[Nelson Vergel]

The FDA Wants More Information about Flibanserin, the female Viagra

www.excelmale.com/showthread.php?1597-The...Flibanserin...

flibanserin, ...

[TD="class: gsc-table-cell-snippet-close"] Sprout Pharmaceuticals said Tuesday that the Food and Drug Administration wants to see more data on how the company's drug,

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Drug that increases sex drive in women [Archive] - ExcelMale.com ...

www.excelmale.com/archive/index.php/t-2539.html

Flibanserin is a novel, non-hormonal drug for the treatment of HSDD in pre- and postmenopausal women, although the application submitted to ...

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FDA Panel Backs Fibanserin, the First Female Libido Drug

www.excelmale.com/showthread.php?4020-FDA-Panel-Backs...

Flibanserin's risks include low blood pressure and fainting. “I have serious, serious, serious safety concerns,” said Dr. Walid Gellad of the.

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A Viagra-like Pill for Women Gets Another Chance for FDA Approval ...

www.excelmale.com/archive/index.php/t-3275.html

flibanserin, ...

[TD="class: gsc-table-cell-snippet-close"]1214 The pill has been twice rejected, but Sprout Pharmaceuticals said Tuesday, Feb. 17, 2015, it is refiling its application for

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[J2048b]

wow sooo my wife might might want and desire me after all these years!! FINALLY!! YAY BABY!

 

[Phoenix]

IMHO I would take a wait and see approach. New drugs can take years to reveal all their advantages and disadvantages. Addyi (flibanserin) may have some of the nasty side effects that SSRIs do.

 

[J2048b]

yeah plus they are stating it could take up to 6 weeks to see effects, heck ill just give her cialis or something!!

 

[Nelson Vergel]

FDA's Big Mistake: Expect Flibanserin to Be Pulled From the Market in a Few Years

 

[croaker24]

According to the NY Times -

"In one trial, for instance, women who took the drug had an average of 4.4 “satisfying sexual experiences” a month, compared with 3.7 for women getting a placebo and 2.7 before the study began. The drug did not increase desire more than a placebo when measured by a daily diary, but did do so modestly when measured by a monthly questionnaire."

Maybe they would do better selling a placebo, without all the side effects. These women groups are simply pushing an agenda based on "Men have Viagra, we should have *something*", and all these groups were funded or supported by Sprout.

I think we all know how complicated libido is, health issues/hormones/family responsibilities/children/stress/job/stability of marital relations and so on, and to think this one potentially dangerous drug will magically fix all this is absurd.

 

[Nelson Vergel]

This is the next product another company will try to get approved (Libigel, a T gel for women, got declined for approval a few years ago).

"Trimel Pharmaceuticals Corporation (TSX:TRL) today communicated its support of the U.S. Food and Drug Administration's (FDA) decision to approve ADDYITM (flibanserin; developed by Sprout Pharmaceuticals), the first treatment option for female sexual dysfunction (FSD). Trimel is currently developing TEFINATM, a ‘use as required', low-dose nasal testosterone gel treatment for female orgasmic disorder, a subset of FSD."

 

[CoastWatcher]

This is the next product another company will try to get approved (Libigel, a T gel for women, got declined for approval a few years ago).

"Trimel Pharmaceuticals Corporation (TSX:TRL) today communicated its support of the U.S. Food and Drug Administration's (FDA) decision to approve ADDYITM (flibanserin; developed by Sprout Pharmaceuticals), the first treatment option for female sexual dysfunction (FSD). Trimel is currently developing TEFINATM, a ‘use as required', low-dose nasal testosterone gel treatment for female orgasmic disorder, a subset of FSD."

Trimel is a Canadian company, and one that we here in Canada are hearing more and more about in the mainstream press. They are pushing hard in the hormonal area. They brought Natesto to market, the testosterone-based nasal gel, last year.