FDA Asks For More Studies on “Female Viagra”

For years the pharmaceutical companies have worked to create a female version of Viagra. In 1998, when Pfizer first rolled out its little blue pill, sales skyrocketed immediately. The instant success explains why several pharmaceutical companies are racing to get a female version of the blockbuster pill on the market.

Drug to boost a woman’s libido

Sprout Pharmaceuticals says the company is close to releasing a drug called flibanserin, which can treat premenopausal women who have a recurrent lack of interest in sex. This condition, which is called hypoactive sexual desire disorder or HSDD, can cause extreme stress, according to CBS News.

FDA says ‘not so fast’

The company has submitted the drug to the Food and Drug Administration, but the government agency says more tests are needed before it gives the green light.

The FDA wants to know how the drug interacts with other medications. The FDA also asked the company to investigate one of the main side effects of the pill: drowsiness.

Despite this setback, Sprout released a statement calling the FDA request “a significant step toward the approval of flibanserin.” The studies that the FDA requested are small, which should allow Sprout to resubmit its application in a few months.

Previous setbacks

However, it’s not the first time the company has battled the FDA. In fact, the agency has denied the company’s applications twice. The company filed a “formal dispute” over the agency’s decision not to approve the drug in December. The appeal process has resulted in the FDA asking for three specific studies.

The company says it will work with the FDA to ensure the drug is safe and effective for women.

“We are committed to working closely with the Agency to finally provide premenopausal women affected by HSDD with a medical treatment option,” Sprout Pharmaceuticals President Cindy Whitehead said in the statement.