Post by gallito on Sept 23, 2015 19:54:40 GMT -5
Flibanserin, a drug produced by Sprout Pharmaceuticals and marketed as Addyi, recently passed an FDA advisory committee meeting.
It has been criticised as having only marginal benefits.
Unlike Viagra, which affects blood flow to the genitals, Addyi is designed to help women regain their sex drive by boosting levels of brain chemicals.
Sprout said trials had shown an increase "in the number of satisfying sexual events", although experts suggest the test results were modest.
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.
What is hypoactive sexual desire disorder (HSDD)?
A chronic or ongoing lack of interest in sex to the point that it causes a woman relationship problems and distress
It can be caused physically - for example by hormonal changes or surgery, or conditions such as diabetes, arthritis or cancer
It can be caused psychologically - depression, stress, low self-esteem or previous sexual abuse
Patients will have had no previous problems with sexual desire
It can occur regardless of sexual activity, the situation or the sexual partner
Current treatments are varied. Can include changes to medication and/or lifestyle, counselling and oestrogen therapy, or a combination of these
An estimated 8-14% of US women aged 20-49 have the condition, surveys suggest
'Female Viagra' - what you need to know
But an FDA advisory meeting on 4 June concluded by 18 votes to six that it should be approved.
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.
www.bbc.com/news/world-us-canada-33979526
It has been criticised as having only marginal benefits.
Unlike Viagra, which affects blood flow to the genitals, Addyi is designed to help women regain their sex drive by boosting levels of brain chemicals.
Sprout said trials had shown an increase "in the number of satisfying sexual events", although experts suggest the test results were modest.
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.
What is hypoactive sexual desire disorder (HSDD)?
A chronic or ongoing lack of interest in sex to the point that it causes a woman relationship problems and distress
It can be caused physically - for example by hormonal changes or surgery, or conditions such as diabetes, arthritis or cancer
It can be caused psychologically - depression, stress, low self-esteem or previous sexual abuse
Patients will have had no previous problems with sexual desire
It can occur regardless of sexual activity, the situation or the sexual partner
Current treatments are varied. Can include changes to medication and/or lifestyle, counselling and oestrogen therapy, or a combination of these
An estimated 8-14% of US women aged 20-49 have the condition, surveys suggest
'Female Viagra' - what you need to know
But an FDA advisory meeting on 4 June concluded by 18 votes to six that it should be approved.
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.
www.bbc.com/news/world-us-canada-33979526