MEDICAL authorities in the US are on the verge of approving a new drug nicknamed female Viagra. The drug is aimed at increasing the sexual drive among women after a panel asked the US Food and Drug Administration (FDA) to give it the go-ahead.
Known as Flibanserin, the drug has been approved by an advisory panel, who said it is handy because it could help increase women’s sex drive. If the FDA goes ahead and approves the drug, it would be the first drug on the market to boost female libido.
Legally, the FDA is not required to follow the advice of the panel but it often does. Experts voted 18-6 in favour of allowing the drug on the market but suggested some additional risk-control measures to make sure doctors prescribe it only to patients who need it and that women are aware of the risks.
Flibanserin, which is aimed at pre-menopausal women, can have significant side effects including nausea, dizziness and sleepiness. However, during the public comment period, women who had taken the drug said the benefits were considerable.
Dr Christina Chang, who addressed the panellists on behalf of the FDA, asked the committee to weigh in on the evidence of benefits and risks in women studied. She added that safety concerns include sleepiness, fainting, low blood pressure and the potential for hormonal contraceptives and alcohol use to make side effects worse.
Experts at the hearing also raised questions about the possibility of Flibanserin being used as a date-rape drug and the increased risk of breast cancer seen in one of two studies on lab animals. Two attempts at bringing the drug to market have already failed in 2010 and 2013, given what experts described as inconclusive advantages when compared to a placebo.
After it was initially rejected by the FDA, Flibanserin was sold by its developer, the German company Boehringer Ingelheim, to a US firm called Sprout Pharmaceuticals. According to documents on the FDA website, women taking Flibanserin reported on average 4.4 sexually satisfying encounters per month, compared with 3.7 in a placebo group and 2.7 before beginning the study.
Among the six who voted against the approval, concerns included negative interactions with alcohol, risks such as fainting and low blood pressure, the drug’s minimal effectiveness and the lack of long-term data on safety. However, the majority of the experts said the approval should provide an option for women who suffer from loss of interest in sex for the first time, as long as certain risk management options beyond labelling are instituted, such as doctor training and post-marketing studies.
Flibanserin’s aphrodisiac properties were discovered accidentally when it was tested as an anti-depressant, according to its manufacturer. Viagra’s ability to cause an erection was also discovered accidentally after it was tested as a heart medication.
Other big drug companies have already thrown in the towel when it comes to developing a female version of Viagra. In the past, the likes of Pfizer and Procter and Gamble have all considered developing a drug. Source: Nigeria Watch
