June 28, 2011
/PRNewswire/ -- Palatin Technologies, Inc. (NYSE Amex: PTN) announced today that enrollment of patients has commenced in Palatin's 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 within the U.S. and
, 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 have begun patient enrollment for the Phase 2b study of bremelanotide, the most advanced on-demand investigational treatment for FSD. Pending successful completion of the trial, the data will be used to support discussions with the FDA prior to initiation of Phase 3 studies," stated
, Ph.D., President & CEO of Palatin. "We believe bremelanotide has the potential to transform the treatment of patients with FSD, an area of significant unmet need."
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
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
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).