Palatin Technologies, Inc., a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics, has completed the treatment of last patient in its phase II B clinical trial evaluating the efficacy and safety of bremelanotide for treatment of female sexual dysfunction (FSD). Database lock is expected by the end of September and top-line trial results are expected in the first-half of next quarter.
“We are pleased to reach this important milestone of completing the patient treatment part of this comprehensive trial and look forward to compiling and analyzing the data,” stated Carl Spana, PhD, 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.”
Approximately 400 premenopausal women, diagnosed with female sexual arousal disorder, hypoactive sexual desire disorder or both, were enrolled in the study. Patients were treated for 16 weeks and were randomized to one of four double-blind treatment groups and received 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 objectives of the phase II B trial are to demonstrate and identify safe and effective SC doses of bremelanotide and to define endpoint measurements to support transition to phase III studies. Depending on the results of this trial, phase III studies are anticipated to start in the second-half of calendar year 2013.
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. 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 per cent of women suffer from some form of FSD, with up to about 15 per cent having associated personal distress required to establish a diagnosis of FSD.
There are no drugs in the United States approved for FSD indications.
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).