The company seeking to market a female version of Viagra got some deflating news from the Food and Drug Administration (FDA) last month after the agency demanded further testing of the drug before okaying its use in the U.S.
The FDA announced last month that it wants more data on flibanserin, a non-hormonal drug treatment for premenopausal women suffering from Hypoactive Sexual Desire Disorder (HSDD). FDA officials told the company Sport Pharmaceuticals that it wants further studies to determine how the drug interacts with other medications, affects driving abilities and induces drowsiness.
Nearly 10 percent of women who took part in earlier trials reported sleepiness while taking the pill. The company now views this as a hurdle in their 15-year research of the drug.
The approval of the drug became a rallying point for women advocates and some members of Congress, believing regulators are more interested in the approval of enhancement drugs for men than women. The quest for the “female Viagra” has sparked some questions about how much of a libido lift is needed as well as society’s possible disturbance to the sexual desires of women.
“I do think there’s some type of discrimination considering all the commercials marketing men’s sex drive than females,” said Political Science major Tatiana Sangare. “Our culture makes it appear men are the only ones who can be pleasured while women are looked at as sex objects.”
USA Today said the FDA’s request has put the company in a predicament after receiving a second rejection for the drug. Flibanserin, or the “little pink pill”, was originally created as an antidepressant by Boehringer Ingelheim, a German pharmaceutical company, but due to a number of tests it was found to be ineffective in the treatment of depression.
In 2006, it was found to help in improving female sex drive. Studies were conducted where 10 to 20 percent of women suffered from HSDD, an absence of sexual desire. Researchers claim this outnumbers the number of men suffering from the disorder.
“Yeah they deserve to enjoy having sex as much too, but those side effects can hurt you,” said Sangare.
“Personally, I just don’t understand why women would need that; women are stimulated differently than men,” said the Director of the Health Center Sharon Hawkins. “Everybody’s different, everybody’s body reacts to different things, I think women need to know what works for them.”
In 2010, Boehringer decided to cease its attempts in trying to get the drug approved by the FDA, after a panel unanimously rejected its approval. The FDA had questioned the safety and success of the drug after pointing out a number of side effects such as dizziness, nausea and fatigue. The agency also had concerns about taking the drug with alcohol, hormonal contraceptives and other pills.
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