The Food and Drug Administration (FDA) is one step closer to approving flibanserin, otherwise known as the female version of Viagra. An advisory committee to the FDA voted last week to recommend that the FDA approve the drug under certain conditions. The FDA’s decision regarding the approval of flibanserin is expected by August.

This is exciting news because the recommendations of the advisory committees are usually followed. However, it is certainly a wait-and-see because they are also not always followed. The FDA has already rejected the approval of flibanserin twice due to potential side effects of nausea, fainting, dizziness, low-blood pressure, and sleepiness, all of which they say outweigh the benefits of the drug.

Flibanserin is a drug that has been developed to help premenopausal women who suffer from having a low libido, or low sexual desire. Just like the man’s version of Viagra is known as “the little blue pill”, flibanserin is a little pink pill that is now being known as the “female Viagra”. Women who suffer from low sexual desire are clinically diagnosed as having a condition called hypoactive sexual desire disorder. 

While Flibanserin has become known as the ‘female viagra’, it actually works very differently than Viagra. Viagra works by improving the physiological problems associated with erectile dysfunction. Flibanserin works by acting on the neurotransmitters in the brain that affect sexual desire. The drug targets the ‘feel-good’ hormones of the brain, also known as dopamine and serotonin. This is also how an antidepressant works. Flibanserin was actually initially developed and previously tested and for use as an antidepressant, but failed in clinical trials. As for side effects of flibanserin, the most common side effects include nausea, sleepiness, dizziness, and fainting.

Flibanserin was developed by Sprout Pharmaceuticals. The company’s most recent study on the drug shows significant promise in working successfully to treat low libido in women. They recently presented the results of a series of double-blind clinical trials that showed flibanserin worked better than the placebo to improve women’s sexual desire by increasing the number of sexually satisfying events and lowering the amount of distress women experience as a result of their low libido.  

The results showed that after 24 weeks, 46 to 60 percent of the women in the trials had benefited from taking flibanserin. However, some committee members argue that after taking the placebo effect into account, only about 10 percent of the women benefited from taking the drug.

Viagra for men was approved by the FDA back in 1998. So why is there still not an approved version of Viagra for women? There have been a number of attempts at a female Viagra, however, the FDA has not approved any of them. The controversy seems to surround the fact that the FDA has described this condition that women suffer from as an “unmet medical need.”

The FDA is also concerned about flibanserin’s interaction with other drugs, such as hormonal birth control pills and alcohol, whose interactions could potentially lead to accidents such a car wrecks or other hazards. There was also concern about breast cancer after a cancer study showed an increased risk in breast cancer tumors in mice.

Will flibanserin be approved by the FDA? Only time will tell. The deadline for the FDA’s decision is August 18th. And if it is approved, will the drug work just as good as Viagra worked for men?