Flibanserin 100mg can be used to increase the number of satisfying sexual events (SSE) and sexual desire as proved by the data collected from the Phase III clinical trials. Flibanserin, an investigational compound, also helps in decreasing the distress, which is caused as a result of the Hypoactive Sexual Desire Disorder (HSDD). Boehringer Ingelheim developed it for the treatment of HSDD in pre-menopausal women. HSDD leads to distress in patients by decreasing the sexual desire. It can also affect the relations. The findings were presented in Lyon, France at the 12th Congress of the European Society for Sexual Medicine. It included data from two North American trials (DAISY® and VIOLET®). In both these trials, researchers studied the effect of flibanserin 100mg in pre-menopausal women suffering from HSDD.
“HSDD is a complex condition that can cause distress and negatively impact a woman’s self-esteem. With this data, we are making exciting progress in women’s sexual health research, as flibanserin is the first in a class of drugs being studied for this condition in pre-menopausal women. This is an important milestone for an under-recognised condition for which there is no FDA-approved treatment,” said Anita Clayton, M.D., one of the lead study authors and professor of psychiatry and neurobehavioral sciences, University of Virginia.
The researchers studied 1,378 pre-menopausal women with HSDD and they found that use of the flibanserin 100mg helped in raising the frequency of SSE (increasing from 2.8 at baseline to 4.5 at study end) versus placebo (2.7 at baseline increasing to 3.7 at study end). He study was conducted over 24 weeks. The study showed that Flibanserin also helped in improving the sexual desire.
The findings added that Flibanserin improved sexual functioning significantly (as measured by the FSFI total score). It also helped in decreasing the distress related to sexual dysfunction and to low sexual desire.
The commonly reported adverse events (AEs) with flibanserin 100mg emerged during the first two weeks of treatment, but they were not severe.”Sexual desire disorders can affect women of all ages, at any stage of life. Boehringer Ingelheim is pleased to present this data, which provides valuable scientific knowledge about HSDD,” said Peter Piliero, MD, executive director, Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “
About the North American Phase III Trial
In this trial, the effect of flibanserin was studied at 25, 50 and 100mg doses. In the pooled analysis, the researchers studied data taken from two 24-week randomised, placebo-controlled North American trials. In the analysis, the researchers analysed women with generalised, acquired HSDD, who had received either flibanserin 100mg or placebo. The study showed that Flibanserin 100mg helped in increasing the number of SSE and sexual desire. It also decreased the distress, caused due to HSDD. The women, who were selected for study, in were in heterosexual relationships with a partner for at least one year. These women were stable, communicative, monogamous and were using contraceptive pills. Around 40% of these women were also using hormonal contraception.