Women across the world who have low libido could soon have a glow on their face if they take a shine to flibanserin, erroneously dubbed the `female Viagra', which the US Food and Drug Administration approved on Tuesday to critical reviews and universal interest.
While Viagra treats men with erectile dysfunction, flibanserin is aimed at combating female sexual interest arousal disorder which affects women with low libido. Unlike Viagra and allied erectile dysfunction drugs which simply increase blood flow to the penis, flibanserin works on the brain, targeting neurotransmitters affecting sexual desire. Originally developed as an antidepressant, it is to be taken daily to be effective.
Sprout Pharmaceuticals, which won the FDA approval after two previous rejections for a pill it will market under the brand name Addyi, said in a press release the drug corrects “an imbalance of levels of these neurotransmitters by increasing dopamine and norepinephrine (both responsible for sexual excitement) and decreasing serotonin (responsible for sexual inhibition)“. The approval is not with out controversy: opponents range from closet Talibanist conservatives to those who insist that the drug has not been proven safe for long term-use, its efficacy has not been fully established and there are too many side-effects.
Sprout itself germinated controversy by backing a campaign called `Even the Score', aimed at pressuring the FDA to approve the drug, arguing that while there are several approved treatments for male sexual dysfunction, pervasive gender bias had foiled treatment for women.
After a hearing in June, an FDA panel voted 18-6 in favour of putting flibanserin on the market but emphasized that the drug manufacturer would be required to include safety warnings when the drug is marketed.Side-effects cited include dizziness, nausea, fatigue, somnolence and insomnia. Both the drug company and marketing executives maintain that Addyi or flibanserin is not the female equivalent of Viagra nor is it designed to address a slump in the female sex life; it is a medical treatment for women suffering from a real disorder.
The big question now is how many people will use Addyi? According to one survey , about 10% of women suffer from hypoactive sexual desire disorder (HSDD).
The FDA said the drug was approved for women whose loss of sexual desire causes marked distress or interpersonal difficulty and is not the result of illness, relationship problems or side effects of other medicines.
Dr Lauren Streicher, associate professor of clinical obstetrics and gynecology at North western University , said she sensed great interest for a drug like Addyi among her patients.She said the drug's availability would encourage many women to talk to doctors about their sexual problems for the first time.
The news sent shares of Pa latin Technologies, which is creating a rival drug for HSDD, up about 30% to $1.21.
Palatin's experimental treatment called bremelanotide is now in late-stage trials and works differently from Addyi. It attempts to activate certain brain pathways.
Palatin Technologies in a statement said its drug, if approved, would only be taken as needed, not on a daily basis like Addyi, thereby providing women "greater control and flexibility in their treatment."
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