Pharmaceutical

Drug company to seek FDA approval for first ‘female Viagra’

viagra Drug company to seek FDA approval for first female ViagraSprout Pharmaceuticals says it will resubmit an application for Food and Drug Administration (FDA) approval for its “female Viagra” pill by the end of the year in hopes of having the first marketed pill to treat hypoactive sexual desire disorder, or HSDD, in women.

HSDD is the most commonly reported female complaint and is characterized by a decreased libido that causes personal distress or personal difficulties. An estimated 1 in 10 women are affected by the disorder.

Filbanserin is a 5-HT1A receptor agonist and 5-HT2A receptor antagonist that was initially investigated as an antidepressant. Preclinical studies suggest that fibanserin targets receptors in selective brain areas that helps restore a balance in inhibitory and excitatory effects to act as a stimulator of sexual desire.

Fibanserin was originally developed by Boehringer Ingelheim but the company backed off the pill in October 2010 after the FDA questioned its efficacy in clinical trials. The drug rights were transferred to Sprout Pharmaceuticals, which continued development and resubmitted the drug for FDA approval in 2013. Once again, the agency rejected the drug saying new studies needed to be conducted to determine if filbanserin impairs patients’ ability to drive or if it interferes with biochemical pathways.

The latest studies found that the drug enabled women to have twice as many satisfying sexual events and a 50 percent increase in sexual desire. About 15 percent of trial participants dropped out of the study because of the drug’s side effects, which include fatigue, nausea and dizziness.

If fibanserin receives a positive review by the FDA, it could hit the market as early as the middle of 2015. If approved, the drug is expected to be marketed under the name Girosa.

Source: WRAL.com