CRANBURY, N.J., Feb. 26, 2016 /PRNewswire/ — Palatin Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, announced that data on a bremelanotide and alcohol use interaction Phase 1 study were presented today in a Research Podium Session at the International Society for the Study of Women’s Sexual Health (ISSWSH) annual meeting taking place February 25 to 28 in Charleston, South Carolina. The presentation concluded that, in a Phase 1 study, bremelanotide and ethanol can be safely co-administered and are generally well tolerated with no reports of drug-related serious adverse events. A total of twenty-four subjects were enrolled, consisting of twelve women and twelve men.
Leonard R. DeRogatis, Ph.D., Director of the Maryland Center for Sexual Health and a consultant to Palatin, presented an abstract titled “A placebo-controlled, randomized, double-blind, three period, three-way crossover study on the hemodynamic and pharmacokinetic interactions of bremelanotide and ethanol.”
Carl Spana, Ph.D., President and CEO of Palatin, commented, “We are pleased to report the positive results of this alcohol interaction study. Alcohol interaction studies are required by the Food and Drug Administration, and these results support our belief that there is no adverse interaction between bremelanotide and alcohol use.”
Top-line results of Palatin’s ongoing Phase 3 clinical trials of bremelanotide for female sexual dysfunction are on target for release in the third quarter of calendar year 2016. Assuming the Phase 3 trials are successful, Palatin will file a New Drug Application with the FDA in the first half of calendar year 2017.
About Bremelanotide for Female Sexual Dysfunction
Palatin is developing bremelanotide as a subcutaneous, on-demand treatment of female sexual dysfunction (FSD) in premenopausal women diagnosed with hypoactive sexual desire disorder (HSDD). 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).
Bremelanotide is an as-needed (not chronic), centrally-mediated medication, unlike flibanserin (ADDYI®) or certain other FSD treatments in development that require daily administration. Studies have shown that bremelanotide starts working within 30 to 60 minutes of administration and remains effective for approximately eight hours, providing women with control and flexibility in their treatment as well as a quick response.
About Female Sexual Dysfunction
Female sexual dysfunction covers multi-factorial conditions that have anatomical, physiological, medical, psychological and social components. We plan to seek approval of bremelanotide for the largest category of FSD, hypoactive sexual desire disorder (HSDD).
HSDD is a medical condition marked by a lack of sexual thoughts and desire for sexual activity, which causes a woman distress or puts a strain on the relationship with her partner, and cannot be accounted for by another medical, physical or psychiatric condition, or as a result of other medication. It is estimated that one in 10 women may have the signs of HSDD at some point in their life, and as such HSDD represents a major opportunity to address a tremendous medical need.
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.
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 relating to bremelanotide, potential labels and 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 nonclinical, preclinical and toxicology studies, result of clinical trials, regulatory actions by the FDA and the need for regulatory approvals, regulatory actions by the USPTO, 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.