FDA approves female viagra
The new drug to treat sexual dysfunction in premenopausal women has received official approval from the US Food and Drug Administration.
Manufactured by Sprout Pharmaceuticals, flibanserin ( brand name Addyi) nicknamed the “ female Viagra” has been given the green light by the FDA for treatment of hypoactive sexual desire disorder (HSDD)- a condition which creates low sexual desire. One in ten women develop HSDD and 40 per cent experience the condition at some point in their lives. As well as hormone changes or physical factors such as fatigue or lifestyle habits, psychological factors such as low self-esteem, stress and mental health also contribute to low sexual desire (LSD).
The drug corrects an imbalance in brain chemicals that are responsible for sexual desire. The FDA says a 100-mg dose of the drug should be taken once daily just before bedtime prescribed by their doctor. They should discontinue use if they experience no improvement in sexual desire within 8 weeks.
The FDA reached their decision by conducting an analysis of three randomised, double blind, placebo- controlled trials involving 2400 women of an average age of 36 years who has HSDD. For a 24 week period, the women either took placebo or a 100-mg of Flibanserin before bedtime. The women who took flibanserin reported a modest increase in sexual desire and the number of sexual events during the study period, as well as a reduction in distress because of low sexual desire.
The most common after effects identified were nausea, dizziness, fatigue, insomnia and dry mouth. However this should be avoided at all costs with alcohol, as it could result in hypotension, severe low blood pressure and loss of consciousness. FDA previously rejected the drug twice before once in2010 and again in 2014 because of the side effects. Flibanserin comes with a boxed warning informing patients about the risk of hypo tension and concussion if taken with alcohol, as well as serious warning patients with liver impairment or those taking moderate or strong CYP3A4 inhibitors to avoid use of the drug.
The approval of flibanserin come with a risk evaluation and mitigation strategy (REMS) which requires all prescribers enrol in and complete a training program before treating patients with the drug.
Last June the US Medical News Today investigated “whether flibanserin will really help women with low sexual desire”
According to Cindy Whitehead CEO of Sprout Pharmaceuticals “It has been a remarkable journey to get to this breakthrough moment. Today we celebrate what this approval means for all women who have long waited a medical treatment option for this life impacting condition.”
Flibanserin, will be available from late October 2015, expected to cost between £20, $30 and £50, $75 for women with medical insurance. The new drug could ramp up the sex lives of women who take it, just as it has done for men.