AUSTIN, Texas — A new drug candidate undergoing clinical tests at The University of Texas at Austin has shown significant results in treating female sexual arousal disorder (FSAD) in post-menopausal women. Results of the tests were announced by UT psychologist Cindy Meston Saturday (June 24) at the 26th conference of the International Academy of Sex Research in Paris, France.
NitroMed Inc. and UT Austin reported positive Phase II clinical results of NitroMed¤s FSAD therapeutic NMI-870, a nitric oxide (NO)-enhanced compound of the alpha2 blocker yohimbine. In the study, the drug treatment was found to increase vaginal blood flow in post-menopausal women diagnosed with FSAD. The investigators measured response using a proven psychophysiological evaluation technique for sexual arousal known as vaginal photoplethysmography.
“NO-enhanced yohimbine has a remarkable safety profile and has demonstrated extremely encouraging results in generating an increase in vaginal blood flow as compared to both placebo and yohimbine alone,” said Meston, a UT Austin assistant professor of clinical psychology. “There is a dire need for medicines that can aid in treating sexual dysfunction in females. Based on our study, this product holds excellent potential as an FSAD treatment.”
“NO is a known mediator in smooth muscle relaxation, a key component to treating FSAD,” said Manuel Worcel, M.D., president of NitroMed and co-author of the study. “This study validates in female sexual dysfunction what has been observed in NMI-870¤s successful Phase I and Phase II trials in male erectile dysfunction. We have shown that the product causes an increase in the localized production of NO, which allows for a resulting blood flow increase in reaction to sexual stimuli.”
The study was conducted at UT Austin as a randomized, double blind, placebo-controlled, three-way crossover clinical trial comparing the effects of the orally administered NMI-870 to the effects of yohimbine alone and placebo. Patients were 23 post-menopausal women who met DSM IV criteria for FSAD. The psychophysiological sexual response diagnostic employed, vaginal photoplethysmography, measures variations in vaginal blood flow.
Statistics show that FSD affects an estimated 30 to 45 million women in the United States. Although treatment of sexual dysfunction in males recently has been improved by pharmaceuticals currently marketed and in development, the discovery of treatments for FSD has been limited. The United States Food and Drug Administration recently has issued draft guidance for industry regarding clinical development of drug products for FSD. The drafting of these guidelines underlies the importance of FSD treatment development.
Meston’s primary area of research over the past 10 years has been the role of the sympathetic nervous system in female sexual arousal. Her laboratory at UT Austin is one of only a few laboratories in North America with the capability to examine female sexual function using psychophysiological techniques. In other studies on female sexual function, Meston has found that acute exercise aids sexual arousal in women. She also investigates ways to counter the adverse sexual side effects commonly associated with antidepressants. Her research has been cited in articles in Newsweek, The New York Times, Scientific American and various health magazines.
The next step in the research is to allow women to use the drug in a more natural environmental. “Examining the efficacy in a non-laboratory setting will prove the ultimate test of the drug’s benefits to women,” Meston said.
Note to Editors: Meston can be reached at (512) 232-4805; contacts for NitroMed Inc. include Chief Executive Officer Michael D. Loberg, (781) 275-9700 and Michael Mitchell, Feinstein Kean Healthcare, at (617) 577-8110.