The American drug industry’s decade long efforts to get a libido boosting pill for women approved by the FDA experienced a major breakthrough in Thursday, as panel of the Food and Drug Administration or FDA’s expert advisors voted in favor of the female counterpart for Viagra.
The drug, called Flibanserin is being developed by Sprout Pharmaceuticals; and Cindy Whitehead, a senior executive at the firm, is spreading the development process. After facing rejection, twice since 2010, from the FDA for being m
The drug, called flibanserin, is being developed by Sprout Pharmaceutical; and Cindy Whitehead, a senior executive at the firm, is spearheading the development process. After facing rejection, twice since 2010, from the FDA for being having more risks than benefits, the company returned with advanced clinical data and several testimonials from women who described how the loss of sexual excitement adversely affected their personal lives.
This pill, when taken, tends to change the levels of three chemicals in the brain in ways that can increase the sex drive of premenopausal women suffering from loss of libido.
The clinical trials showed a modest increase in the benefits of the drug. Those who used it experienced one more sexually satisfying event per month than others who used a placebo pill. Potential side effects including low blood pressure, dizziness and fainting were also recorded.
The campaign divided an otherwise close-knit women’s health community. Groups like the National Women’s Health Network and Our Bodies Ourselves refused to participate, citing gender bias as the reason. Other groups cited the number of risks that the drug still had which outweighed the limited benefits recorded in the trials.
Advocated of the campaign believed that the drug had a potential to improve the lives of women in the US. The experts of FDA also acknowledged the need of FDA approved drugs that catered to the sexual needs of women.
The FDA panel encouraged Sprout to take necessary steps to limit the risk of the new drug, and advised warnings to be clearly described on the label of the drug while also educating potential prescribers about the drug and its risks. The FDA is known to follow the advice of its experts and an official decision regarding flibanserin is expected in August.