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posted by martyb on Wednesday August 19 2015, @04:23PM   Printer-friendly
from the what-color-is-the-pill? dept.

Flibanserin or Addyi, a female libido-enhancing drug created by Sprout Pharmaceuticals, has been approved by a U.S. Food and Drug Administration (FDA) advisory committee:

It was rejected by the FDA twice for lack of effectiveness and side effects like nausea, dizziness and fainting. Women taking the drug reported between half and one more sexually satisfying event per month - results experts admitted were "modest". Originally the drug was produced by German company Boehringer Ingelheim. Sprout bought the drug from that company after it was turned down by the FDA.

Documents from the 4 June FDA advisory meeting describe the drug's purpose of "treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women". Women would take it each night. A doctor would have to determine whether a woman seeking the pill was suffering from a disorder characterised by a lack of sexual fantasies and desire, causing the woman distress. Currently, there is nothing on the US market approved for treatment of HSDD or another condition, female sexual interest/arousal disorder (FSIAD). "This condition is clearly an area of unmet medical need," the FDA documents said.

Reuters adds that the FDA will require a warning over "potentially dangerous low blood pressure and fainting when taken with alcohol."

FDA press release.

Previously: Female Libido Pill Considered by FDA Advisers


Original Submission

 
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  • (Score: 2) by looorg on Wednesday August 19 2015, @06:42PM

    by looorg (578) on Wednesday August 19 2015, @06:42PM (#225118)

    So it is just as with V*agra (apparently you can't use that word, it gets tagged as spam) then. That was initially supposed to be medication for high blood pressure and heart disease. Its current primary use was just a "happy" side effect.

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