In The News: “Female Viagra” for Women

addyi female viagra for women 2015Viagra is a little blue pill that quickly became popular as the ideal treatment for erectile dysfunction in men. Now, there is a little pink pill – dubbed the “female Viagra” – that is believed to have a positive effect on sexual dysfunction in premenopausal women.

It is estimated that 10 percent of the female population develops hypo active sexual desire disorder (HSDD) – a condition whose primary sign is low sexual drive – and up to 40 percent experience this condition at some point. There are a number of psychological factors that contribute to the low sexual desire, including stress, low self-esteem, and mental health problems, as well as hormonal changes and physical factors, such as lifestyle habits and fatigue.

How the “Female Viagra” Corrects HSDD

Flibanserin, also known by its brand name Addyi, was recently tested and approved by the FDA for the treatment of HSDD. The drug, which is manufactured by Sprout Pharmaceuticals, is believed to correct an imbalance of brain chemicals involved in stimulating sexual desire, though the actual mode of action is unclear.

According to the FDA, a 100-mg dose of Flibanserin should be taken once a day, just before going to bed. If there are improvements in sexual desire after taking the drug for 8 weeks, it is recommended that you discontinue.

Studies Leading to Approval of Viagra for Women

The FDA found the drug safe for use after conducting 3 randomized, double-blind placebo-controlled tests with a sample population of around 2,400 women of a mean age of 36 years and with HSDD.

For the duration of 24 weeks, the women were administered with a placebo or 100-mg dose of flibanserin every day before bedtime. The women who took the flibarensin dose reported a modest increase in both sexual desire and number of sexual events during the period of study, as well as a reduction in anguish resulting from low sexual desire.

Risks of Addyi – Women’s Sex Pill

With regard to the safety of the drug, the FDA reported that the most common adverse reactions noted were fatigue, dizziness, nausea, dry mouth, insomnia, and sleepiness.

addyi female viagra risksBefore the approval, the FDA has rejected the drug twice before, in 2010 and 2014, because it was associated with hypertension – extremely low blood pressure, as well as loss of consciousness especially when taken with alcohol.

Consequently, flibanserin was approved based on a risk evaluation and mitigation strategy (REMS) that requires prescribers to attend a training program before administering the drug to patients.

Additionally, the drug comes with a boxed warning alerting patients of the risk of concussion and hypertension if taken with alcohol. There is also a warning for women with liver impairment and those taking CYP3A4 inhibitors to stay away from the drug.