German pharmaceutical manufacturer Boehringer Ingleheim is awaiting FDA approval of a drug known as flibanserin, which the company hopes to market as the women’s counterpart to Viagra.
Unlike Viagra, which was originally developed as a medication intended to treat high blood pressure, Flibanserin was originally developed as a potential antidepressant. Like other modern antidepressants, the drug selectively targets serotonin receptors in the brain. Although the drug failed to show efficacy as an antidepressant during the German company’s clinical trials, the company is now touting the drug’s apparent effectiveness in treating female hypoactive sexual desire disorder (HSDD) and female sexual dysfunction (FSD). According to the company’s official description of the drug:
An intricate interplay between stimulatory neurotransmitter systems (dopamine and norepinephrine) and inhibitory systems (serotonin, 5-HT) is part of the natural sexual response. By modulating these neurotransmitter systems in selective brain areas, flibanserin may correct an imbalance in these systems, which leads to a healthy sexual response
Recently, Boehringer presented results from a Phase III clinical trial of flibanserin at the annual clinical meeting of the American Congress of Obstetricians and Gynecologists (ACOG). The company maintains that these results – along with prior clinical trial data – show that “flibanserin 100mg taken once daily at bedtime significantly increased sexual desire while significantly decreasing the distress associated with HSDD.” The company says that the data show “a significant increase in the number of Satisfying Sexual Events (SSEs).”
Here in the United States, Boehringer has submitted a New Drug Application (NDA) to the FDA requesting approval to market and sell flibanserin for the treatment of HSDD. The FDA’s Reproductive Health Drugs Advisory Committee has scheduled a meeting for June 18, 2010, to discuss the flibanserin NDA and the company’s findings. Women’s health care commentators observe that FDA approval of flibanserin would be a landmark event, given that there are no similar drugs currently approved for sale in the United States.