CRANBURY, N.J., Dec. 10, 2015 /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 needs and commercial potential, today announced it has achieved its patient enrollment target in its two pivotal phase 3 clinical studies of bremelanotide for the treatment of female sexual dysfunction (FSD).
“We are pleased to achieve this major milestone in the development of bremelanotide,” stated Carl Spana, Ph.D., President and CEO of Palatin. “We are grateful for the enthusiastic response from our clinical investigators and strong interest from patients to participate in our Phase 3 reconnect study program.” Dr. Spana further stated that, “This puts us on target to release top-line data results in the third quarter of calendar year 2016.”
Each North American (primarily U.S.) reconnect study is a multicenter (~80 sites), randomized, placebo controlled, parallel-group, eight month trial with an open-label extension phase. The clinical trials are designed to randomize approximately 1100 women (~550 each trial) to evaluate the efficacy and safety of subcutaneous bremelanotide in premenopausal women with hypoactive sexual desire disorder (HSDD) as an on-demand, as-needed treatment. More information on the trial protocol, including trial design and inclusion/exclusion criteria, can be found at http://clinicaltrials.gov.
About Bremelanotide for Female Sexual Dysfunction
Palatin is developing bremelanotide as a subcutaneous, on-demand treatment of FSD in premenopausal women diagnosed with 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 greater 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.
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 potential clinical trial results with bremelanotide, potential actions by regulatory agencies relating to bremelanotide, regulatory plans, development programs and the market potential of 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, the ability of Palatin to enter into one or more agreements relating to the commercialization of bremelanotide, results of nonclinical, preclinical and toxicology studies, result of clinical trials, regulatory actions by the FDA and other regulatory agencies 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.
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SOURCE Palatin Technologies, Inc.