The latest application by Sprout included new information requested by the FDA about how the pill affects driving ability. FDA scientists asked for the data because previous results in company clinical trials found that sleepiness occurred in nearly 10 percent of women who took the drug.
In the new study, Sprout compared the driving ability of women the morning after they took flibanserin with those who took a common sleeping pill or a placebo, the AP reported.
The FDA refused to approve flibanserin in 2010 and again in 2013, citing low levels of effectiveness and such side effects as nausea, dizziness and fatigue.
In an effort to pressure the FDA, groups funded by Sprout and other drug companies began pushing the lack of a female libido drug as a women’s rights issue.
An online petition by a group called Even the Score stated: “Women deserve equal treatment when it comes to sex,” and has collected nearly 25,000 supporters.
The group receives funding from Sprout Pharmaceuticals, Palatin Technologies and Trimel Pharmaceuticals, all of which are working on drugs to treat female sexual disorders. Nonprofit supporters of the group include the Women’s Health Foundation and the Institute for Sexual Medicines, the AP reported.
However, the National Women’s Health Network, a nonprofit advocacy organization, called on the FDA to deny approval of the drug in an organization news release, saying, “Based on our review of the data about flibanserin, it’s clear the problem with this drug is not gender bias at the FDA but rather the drug itself.”
In response to the panel’s action, Cindy Pearson, executive director of the organization, expressed disappointment and said, “Women rely on the FDA to ensure that any drugs or devices market to and used by them are both safe and effective. In this case, we still have serious doubts about women’s ability to make informed decisions about the safety and effectiveness of this controversial drug.”
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Copyright HealthDay News June 2015