Palatin Technologies Announces Completion of All Patient Visits In Phase 3 Clinical Trials of Bremelanotide for Hypoactive Sexual Desire Disorder
CRANBURY, N.J., Aug. 4, 2016 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE MKT: PTN) today announced that the last patient visits in the Company's reconnect studies, consisting of two pivotal Phase 3 clinical trials of bremelanotide for the treatment of female hypoactive sexual desire disorder (HSDD), have been completed.
"We are very excited with the completion of the last patient visits in our Phase 3 reconnect studies," said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. "Patient enrollment and last patient out of the studies were concluded on time. We now look forward to data verification and database lock, which we anticipate occurring in late September, with topline data announced shortly thereafter."
Each Phase 3 study is a multicenter (~80 sites), randomized, placebo controlled, parallel-group, eight month trial with an open-label extension phase. The studies are designed to evaluate the efficacy and safety of subcutaneous bremelanotide, delivered by an autoinjector pen, in premenopausal women with HSDD as an on-demand, as-needed treatment.
About Bremelanotide for Hypoactive Sexual Desire Disorder
Palatin is developing bremelanotide, a centrally-mediated medication, as a subcutaneous, on-demand treatment for premenopausal women diagnosed with HSDD. Bremelanotide, which is a melanocortin 4 receptor agonist drug candidate, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone).
Bremelanotide is dosed as an as-needed (not chronic) medical treatment. This treatment is unlike flibanserin (ADDYI®) and some other female sexual dysfunction treatments in development that require daily administration and life style modifications.
About Female Sexual Dysfunction and HSDD
Female sexual dysfunction (FSD) covers multi-factorial conditions that have anatomical, physiological, medical, psychological and social components. We plan to seek approval of bremelanotide for HSDD, which is the largest category of FSD.
HSDD is a medical condition marked by low desire for sexual activity and a lack of sexual thoughts or fantasies, which causes a woman personal 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 as many as one in 10 premenopausal women may have the signs of HSDD at some point in their life, and as such a treatment for HSDD represents a major opportunity to address a significant 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, potential actions by regulatory agencies, financings and projected operations 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 Food and Drug Administration and the need for regulatory approvals, the availability of suitable financing on acceptable terms, regulatory actions by the United States Patent and Trademark Office, 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.
Posted: August 2016