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'Female Viagra' approved by US drug agency | 'Female Viagra' approved by US drug agency |
(about 7 hours later) | |
The US Food and Drug Administration (FDA) has approved a libido-enhancing drug for women that has been dubbed "female Viagra". | |
Flibanserin, a drug produced by Sprout Pharmaceuticals, recently passed an FDA advisory committee meeting. | Flibanserin, a drug produced by Sprout Pharmaceuticals, recently passed an FDA advisory committee meeting. |
The pill is designed to assist premenopausal women regain their sex drive by boosting levels of certain brain chemicals. | The pill is designed to assist premenopausal women regain their sex drive by boosting levels of certain brain chemicals. |
The drug has been criticised as having marginal effects. | The drug has been criticised as having marginal effects. |
Versions of the pill, which will be marketed as "Addyi", have been submitted for approval in the past but never passed. | Versions of the pill, which will be marketed as "Addyi", have been submitted for approval in the past but never passed. |
It was rejected by the FDA twice for lack of effectiveness and side effects like nausea, dizziness and fainting. | 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". | 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. | 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 as "treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women". | Documents from the 4 June FDA advisory meeting describe the drug's purpose as "treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women". |
Women would take it each night. | 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. | 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). | 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. | "This condition is clearly an area of unmet medical need," the FDA documents said. |
Sprout only has 25 employees. Large pharmaceutical companies like Pfizer, Bayer and Proctor & Gamble have all studied female sexual desire disorder treatment but abandoned plans to pursue it. | Sprout only has 25 employees. Large pharmaceutical companies like Pfizer, Bayer and Proctor & Gamble have all studied female sexual desire disorder treatment but abandoned plans to pursue it. |
Sprout's CEO, Cindy Whitehead, told AP they would promote Addyi carefully. | Sprout's CEO, Cindy Whitehead, told AP they would promote Addyi carefully. |
"We would never want a patient who's not going to see a benefit to take it and tell everyone it doesn't work," she said. | "We would never want a patient who's not going to see a benefit to take it and tell everyone it doesn't work," she said. |
Lobbying by Sprout Pharmaceuticals was backed by the women's rights group Even the Score, which has accused the FDA of gender bias by approving a number of drugs treating erectile dysfunction in men without passing an equivalent for women. | Lobbying by Sprout Pharmaceuticals was backed by the women's rights group Even the Score, which has accused the FDA of gender bias by approving a number of drugs treating erectile dysfunction in men without passing an equivalent for women. |
Are you affected by the issues in this story? How would a 'Female Viagra' drug help you? You can share your experiences by emailing haveyoursay@bbc.co.uk. | |
Please include a telephone number if you are willing to be contacted by a BBC journalist. |