Feb. 17, 2015 -- A drug meant to boost women's sexual desire is being resubmitted for U.S. Food and Drug Administration approval, after being rejected by the agency twice in recent years.
The refiled application for the drug flibanserin comes after a recent lobbying effort by women's groups, consumer advocates and politicians who support approval of the daily pill, the Associated Press reported.
The latest application by Sprout Pharmaceuticals includes 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.
There is no drug on the market for women with low libido and drug companies have been trying to get one on the market since Viagra's successful introduction in the late 1990s.
The FDA refused to approve flibanserin in 2010 and again in 2013 due to low levels of effectiveness and side effects such as nausea, dizziness and fatigue, the AP reported.
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.
For example, an online petition by a group called Even the Score states: "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.
Sprout also sought support from politicians and four members of Congress sent a letter to the FDA urging the agency to reassess the drug.
"There are 24 approved medical treatments for male sexual dysfunction and not one single treatment yet approved for the most common form of female sexual dysfunction," states the letter, signed Rep. Debbie Wasserman Schultz, D-Florida, Rep. Louise Slaughter, D-New York, and two other Democratic congresswomen, the AP reported.
The issue was taken up by a coalition of several women's and consumer health groups who met with the FDA early last year.
"We see this not only as an important unmet women's health issue, but an inflection point for the agency to ensure that similar standards are applied for drug approvals in conditions uniquely affecting women," the leaders of the National Organization for Women, the National Consumers League and four other groups wrote in a follow-up letter to the FDA, the AP reported.