FEMALE VIAGRA GETS FDA APPROVAL

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Good news for some women.

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.

The drug, marketed as Addyi, has been criticised as having marginal benefits.

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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.

Women taking the drug reported between half and one more sexually satisfying event a month – results experts admitted were “modest”.

Versions of the pill have been submitted for approval in the past but never passed.’An unmet need’

It was rejected by the FDA twice for lack of effectiveness and side effects like nausea, dizziness and fainting.

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.

It will be made available through certified health care professionals and pharmacies from October.

lineWhat 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
  • 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
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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.

The FDA said the drug’s purpose was the “treatment of hypoactive sexual desire disorder (HSDD)”.

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.

Culled from BBC News

August 2015

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