‘Female Viagra’ or Flibanserin To Undergo More Trials: FDA

The U. S. Food and Drug Administration, FDA, has asked Sprouts Pharmaceuticals to carry out further trials for the drug 'Flibanserin' or 'Female Viagra'.

Flibanserin boosts low sex drive in females. Its manufacturer Sprouts Pharmaceuticals were asked to take conduct three additional tests to see if it reacts when combined with other medications and how it affects driving abilities. Nearly ten percent of the women in the clinical trial reported sleepiness as a side effect of this drug. The FDA guidelines are welcomed by Sprouts, who consider it as a significant step in allowing the drug, first of its kind to, treat Hypoactive Sexual Desire Disorder (HSDD) in women.

"The FDA has requested that Sprout complete two additional Phase I drug interaction studies and a Phase I driving simulator study," Sprout said in a statement. Cindy Whitehead, president and chief operating officer of Sprouts pharmaceuticals mentioned in a press release, "We are encouraged by the FDA's response and view it as a significant step toward the approval of Flibanserin."

 Earlier, Flibanserin was developed by another pharmaceutical company Boehringer Ingelheim in 2010, but the FDA did not approve the drug and asked for more research, revealed Dr Irwin Goldstein, director of sexual medicine at Alvarado Hospital in San Diego, California, to CNN.

In 2011, Sprouts took charge by resubmitting an application to research on the drug and bring it to the markets. It conducted 14 new clinical trials involving more than 3,000 new patients.

The study (Published in the Journal of Sexual Medicine) tested the safety and potency by giving 100 milligrams of Flibanserin before bedtime to premenopausal women (average age 36.6 years) with HSDD for 24 weeks.  At the end of the research nearly 51.8 percent of the women experienced significant benefits compared to the women in the placebo group.  The drug is believed to interact with neurotransmitters of the brain that are associated with moods and sexual desire.

Whitehead added, "In total, more than 11,000 people have participated in clinical trials for Flibanserin. It is not a hormonal treatment and does not appear to affect fertility or interact with birth control medications."

 However, the clinical trial pointed that the drug is not free from side effects like nausea, fatigue, dizziness and sleepiness. The FDA rejected the company's revised drug application in October last year and mentioned it had 'modest effects' in the response letter.