Sprout Pharmaceuticals, тhe manufacturer of flibanserin is appealing the Food and Drug Administration's denial letter to approve the drug, saying the company should provide more information before the agency approved the drug for the U.S. market, CBS News reports.

Since the drug was first denied in June 2010 by an FDA advisory panel, the company added 14 new clinical studies with data on more than 3,000 new patients to its re-submitted application. In total, more than 11,000 women have tried out the drug. More than 5,000 subjects were enrolled in phase III trials, which marks the final stage of efficacy and safety testing.

"Sprout strongly believes that it has satisfied the statutory requirements for approval of flibanserin," Cindy Whitehead, president and chief operating officer of Sprout Pharmaceuticals, said in a press release.

The need for a drug to help sexual dysfunction in women is high. 43 percent of women experience some form of a sexual problem, including low sex drive or hypoactive sexual desire disorder. Women who experience the sexual problem have little sexual fantasies or desires, leading to interpersonal problems or stress.

While there are several treatments for male sexual dysfunction, not much medication exists for women. Pfizer, which manufactures Viagra, stopped working on a female version of the treatment in 2004, and BioSante Pharmaceuticals Inc.’s testosterone gel for women failed two large studies in 2011. Procter and Gamble also submitted a testosterone patch for women called Intrinsa in 2004, but it was denied by the FDA because of concerns of long-term safety. 

Sprout Pharmaceuticals believes that flibanserin could be an answer. The drug works by increasing levels of neurotransmitters dopamine and norepinephrine in the brain, which have been linked to sexual drive. The drug also reduces serotonin, a neurotransmitter that has been associated with lowering sexual desire.