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March 8, 2012 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE Amex: PTN) today announced it has completed enrollment in its Phase 2B clinical trial evaluating the efficacy and safety of bremelanotide for treatment of female sexual dysfunction (FSD). Over 400 premenopausal women, diagnosed with female sexual arousal disorder, hypoactive sexual desire disorder or both, have been enrolled in the study. Patients, who will undergo 16 weeks of treatment, will be randomized to one of four double-blind treatment groups and receive placebo or bremelanotide doses of 0.75, 1.25, or 1.75 milligrams.
The trial is a multi-centered, placebo-controlled, randomized, parallel-group trial designed to measure the safety and efficacy of subcutaneous (SC) bremelanotide doses intended for on-demand use in premenopausal females with FSD. The pharmacokinetics of SC bremelanotide will also be assessed during this trial. The primary efficacy endpoint is the change in the number of satisfying sexual events from baseline to end of study. A number of secondary endpoints will also be examined.
The objectives of the Phase 2B trial are to demonstrate and identify safe and effective SC doses of bremelanotide and to define endpoint measurements to support transition to Phase 3 studies. Depending on the results of this trial, Phase 3 studies are anticipated to start in the first half of calendar year 2013.
"We are pleased to have completed patient enrollment on schedule, and remain on target for results from this study in the third calendar quarter of this year," stated
Carl Spana, Ph.D., President and CEO of Palatin. "Bremelanotide is the only on-demand treatment for FSD in clinical trials in
the United States, and has the potential to transform the treatment of patients with FSD."
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, female sexual arousal disorder, 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, with up to about 15% having associated personal distress required to establish a diagnosis 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).