This article is from the source 'bbc' and was first published or seen on . It last changed over 40 days ago and won't be checked again for changes.

You can find the current article at its original source at http://www.bbc.co.uk/news/world-us-canada-33979526

The article has changed 10 times. There is an RSS feed of changes available.

Version 3 Version 4
'Female Viagra' approved by US drug agency Female libido pill approved by US drug agency
(35 minutes later)
The US Food and Drug Administration (FDA) has approved a libido-enhancing drug for women that has been dubbed "female Viagra". The US Food and Drug Administration (FDA) has approved a libido-enhancing drug for women dubbed the "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 drug, marketed as Addyi, has been criticised as having marginal benefits.
The drug has been criticised as having marginal effects. Unlike Viagra, which affects blood flow to the genitals, Addyi is designed to assist women regain their sex drive by boosting levels of brain chemicals.
Versions of the pill, which will be marketed as "Addyi", have been submitted for approval in the past but never passed. Women taking the drug reported between half and one more sexually satisfying event a month - results experts admitted were "modest".
'An unmet need'
Versions of the pill 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". But an FDA advisory meeting on 4 June concluded by 18 votes to six that it should be approved.
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. The FDA said strict measures would be put in place to ensure patients were aware of the risks, including a warning not to drink alcohol with the drug.
Documents from the 4 June FDA advisory meeting describe the drug's purpose as "treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women". It will be made available through certified health care professionals and pharmacies from October.
Women would take it each night. What is hypoactive sexual desire disorder (HSDD)?
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. There will be warnings of the possible side effects, particularly for those with liver ailments, or if taken with certain other medicines, such as types of steroid.
Currently, there is nothing on the US market approved for treatment of HSDD or another condition, female sexual interest/arousal disorder (FSIAD). The FDA said the drug's purpose was the "treatment of hypoactive sexual desire disorder (HSDD)".
"This condition is clearly an area of unmet medical need," the FDA documents said. A doctor would have to determine whether a woman seeking the pill was suffering from the disorder - characterised by a lack of desire, causing her distress.
Currently, there is no drug 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 said.
The dose would be daily, with some doctors cautioning it would need to be taken for weeks for any benefit to be seen.
The FDA said the treatment should be stopped after eight weeks if there was no improvement.
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 Associated Press it 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. 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.
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.Please include a telephone number if you are willing to be contacted by a BBC journalist.