FSD is a common, yet under-diagnosed problem in women with no currently-approved therapy; we believe bremelanotide holds the potential to treat it unlike anything available to this point.
Columbus, OH (PRWEB) October 31, 2011
Columbus Center For Women's Health Research (CCWHR) has begun enrolling women in Palatin Technologies, Inc. Phase 2b clinical trial evaluating the efficacy and safety of bremelanotide (previously called PT-141), an on-demand, first-in-class melanocortin agonist being developed for the treatment of female sexual dysfunction (FSD).
The multicenter study is a placebo-controlled, randomized, parallel group, dose-finding trial that will test three dose levels of subcutaneously administered bremelanotide in premenopausal women diagnosed with female sexual arousal disorder (FSAD) and/or hypoactive sexual desire disorder (HSDD).
The study is expected to enroll 400 premenopausal women across 40 sites, including CCWHR, within the U.S. and Canada, with a target of randomizing 100 patients to each of three treatment arms and a placebo arm. Patients will undergo 16 weeks of treatment.
The objective of the Phase 2b trial is to measure safety and efficacy of subcutaneous doses intended for on-demand, home use. The primary efficacy endpoint is change from baseline to end of study in the number of satisfying sexual events (SSE).
“We are very excited to be involved in this study of bremelanotide,” stated DR. David Portman, MD, Director and Principal Investigator of CCWHR. “FSD is a common, yet under-diagnosed problem in women with no currently-approved therapy; we believe bremelanotide holds the potential to treat it unlike anything available to this point.”
Results from this study are anticipated in the second half of calendar year 2012 and will guide the final design of anticipated Phase 3 studies. For more information on the clinical trial, please visit http://www.ccwhr.com.
About Female Sexual Dysfunction
Female Sexual Dysfunction (FSD) is a multi-factorial condition that has anatomical, physiological, medical, psychological and social components. FSD includes four disorders: hypoactive sexual desire disorder (HSDD), female sexual arousal disorder (FSAD), sexual pain disorder and orgasmic disorder. To establish a diagnosis of FSD, one or more of these disorders must be associated with personal distress, as determined by the affected women. Approximately 40 million American women are affected by FSD. The National Health and Social Life Survey, a probability sample study of sexual behavior in a demographically representative cohort of United States adults ages 18 to 59, found that approximately 43% of women suffer from some form of FSD. There are no drugs in the United States approved for FSD indications.
Bremelanotide for Sexual Dysfunction
Palatin is developing subcutaneously administered bremelanotide for the treatment of FSD in premenopausal women in patients non-responsive to current therapies. Bremelanotide, which is a melanocortin agonist (a compound which binds to a cell receptor and triggers a response) drug candidate, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone).
About Columbus Center For Women's Health Research
Founded in 1997 by Principal Investigator Dr. David Portman, The Columbus Center for Women's Health Research is an independently run and operated research site specializing in contraception, treatments for vaginal health, sexual dysfunction, osteoporosis, and hormone replacement therapies and their alternatives. CCWHR is located on the east side of Columbus, approximately one mile east of I-270 and Broad Street on North Brice Road.
About Palatin Technologies, Inc.
Palatin Technologies, Inc. is a biopharmaceutical company focused on developing targeted, receptor-specific small molecule and peptide therapeutics. Palatin’s strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin Technologies’ website at http://www.palatin.com.