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.
Read more: http://www.prnewswire.com/news-releases/palatin-technologies-achieves-target-patient-enrollment-in-pivotal-phase-3-studies-for-bremelanotide-for-female-sexual-dysfunction-300191004.html