Detailed analysis of the data results in this trial will be presented at upcoming medical and scientific conferences and publications. Based on the results of discussions with the FDA and external advisors regarding the results of this trial and further development steps, Phase 3 activities are anticipated to start in the second-half of calendar year 2013.
Study Design 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 was a multi-centered, randomized, placebo-controlled, parallel-group dose-ranging trial designed to evaluate the safety and efficacy of three subcutaneous (SC) bremelanotide fixed doses intended for on-demand use in premenopausal females with FSD. The pharmacokinetics of SC bremelanotide was also assessed during this trial.
The objectives of the Phase 2B trial were to demonstrate and identify safe and effective SC doses of bremelanotide and to define endpoint measurements to support transition to Phase 3 clinical studies and activities.About Female Sexual Dysfunction Female Sexual Dysfunction (FSD) covers multi-factorial conditions that have anatomical, physiological, medical, psychological and social components. FSD includes four categories: Sexual Desire Disorders (hypoactive sexual desire disorder [HSDD], sexual aversion disorder), Female Sexual Arousal Disorder (FSAD), Female Orgasmic Disorder (FOD), and Sexual Pain Disorders (dyspareunia, vaginismus). To establish a diagnosis of FSD, one or more of these disorders must be associated with personal distress, as determined by the affected women. In the 2008 PRESIDE study (Prevalence of Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking, reference: Obstet Gynecol. 2008 Nov: 112(5):970-8), Shifren and colleagues studied over 30,000 US women, reporting an age – adjusted point prevalence of sexual difficulties causing personal distress in 12% of respondents. There are no drugs in the United States approved for the treatment of FSD. Bremelanotide is an on-demand treatment for FSD and has the potential to transform the treatment of patients with FSD. Bremelanotide for Sexual Dysfunction Palatin is developing subcutaneously administered bremelanotide for the treatment of FSD in premenopausal women diagnosed with FSD. 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). Conference Call/Webcast Palatin will host a conference call and webcast on November 8, 2012 at 10:00 a.m. Eastern Time to discuss the results of its Phase 2B clinical trial in greater detail. Individuals interested in listening to the conference call live can dial 1-888-471-3843 (domestic) or 1-719-325-2491 (international), pass code 1406375. The webcast and replay can be accessed by logging on to the "Investor/Media Center-Webcasts" section of Palatin's website at http://www.palatin.com. A telephone and webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial 1-888-203-1112 (domestic) or 1-719-457-0820 (international), pass code 1406375. The webcast and telephone replay will be available through November 15, 2012. About Palatin Technologies Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. 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's website at http://www.palatin.com. Forward-looking Statements Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc. such as statements about clinical trial results, potential actions by regulatory agencies including the U.S. Food and Drug Administration (FDA), regulatory plans, development programs, proposed indications for product candidates and market potential for product candidates, are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release. SOURCE Palatin Technologies, Inc.
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