CRANBURY, N.J., April 29, 2014 /PRNewswire/ — Palatin Technologies, Inc. (NYSE MKT: PTN) announced today that data from a 12-week placebo-controlled dose-ranging study using self-administered subcutaneous bremelanotide for the treatment of female sexual dysfunction were presented at the American College of Obstetricians and Gynecologists (ACOG) 2014 Annual Clinical Meeting in Chicago, IL on Monday, April 28, 2014 at 3:45 PM local time. ACOG is the nation’s leading group of physicians providing health care for women.
Bremelanotide is a first-in-class, investigative melanocortin agonist being developed for treatment of female sexual dysfunction (FSD). The data, from Palatin’s Phase 2B study, was presented in three poster presentations. One presentation was titled Bremelanotide for Hypoactive Sexual Desire Disorder: Analyses from a Phase 2B Dose-Ranging Study, and was presented by Dr. David Portman. This is an analysis of the hypoactive sexual desire disorder sub-population which made up the majority of the Phase 2B study population, and will be the patient population of focus for Phase 3. The second presentation was Distress Reduction in Female Sexual Dysfunctions: A Dose-Ranging Study of Subcutaneous Bremelanotide, presented by Dr. Sheryl Kingsberg, and is an analysis of the Female Sexual Distress Scale – Desire/Arousal/Orgasm (FSDS-DAO) efficacy data. The FSDS-DAO is a questionnaire which measures distress associated with sexual dysfunction, which is one of the aspects used in the diagnosis of FSD. The last presentation was Bremelanotide for Female Sexual Dysfunctions: Responder Analyses from a Phase 2B Dose-Ranging Study, presented by Dr. Len DeRogatis, and is an analysis of clinical benefit using the Phase 2B study data.
All three posters are available on Palatin’s website at www.palatin.com.
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.[1] A study of more than 30,000 U.S. women in 2008 reported an age-adjusted point prevalence of sexual difficulties causing personal distress in 12 percent of respondents.[2]
There are no drugs in the United States approved for the treatment of FSD. Bremelanotide is an on-demand treatment and has the potential to transform the treatment of patients with FSD.
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 www.palatin.com.
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 with bremelanotide, potential actions by regulatory agencies including the U.S. Food and Drug Administration (FDA), regulatory plans, development programs, proposed indications for bremelanotide and market potential for bremelanotide, 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.
[1] Frank J et al. Diagnosis and Treatment of Female Sexual Dysfunction. AmFam Physician 2008; 77(5): 635-642.
[2] Shifren JL et al. Sexual Problems and Distress in United States Women: Prevalence and Correlates. ObstetGynecol 2008;112 (5); 968-9.
SOURCE Palatin Technologies, Inc.