The bremelanotide pivotal registration program for the phase 3 reconnect study in the United States for the treatment of female sexual dysfunction (FSD) has begun.
Female Sexual Dysfunction covers multi-factorial conditions that have anatomical, physiological, medical, psychological and social components. Bremelanotide will be for the largest category of FSD, hypoactive sexual desire disorder. To establish a diagnosis of FSD, one or more of the disorders making up FSD must be associated with personal distress, as determined by the affected women (Frank J et al. Diagnosis and Treatment of Female Sexual Dysfunction. AmFam Physician 2008; 77(5): 635-642). 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.
Protocol 301 of the reconnect study is a multicenter (~80 sites), randomized, placebo controlled, parallel-group, eight month trial with an open-label extension phase. It is designed to randomize approximately 550 women in North America 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. Initial data from the study is anticipated in the middle of calendar year 2016.
"We are pleased to achieve this major milestone in the bremelanotide program with the initiation of our phase 3 reconnect study in the U.S," stated Carl Spana, Ph.D., President and CEO of Palatin Technologies, Inc., a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics. "This is a key step in our global strategy to bring bremelanotide to market for the millions of women who have FSD and are seeking a safe and effective treatment."
Spana further stated that, "Our recent $30 million financing has provided the financial resources to start the bremelanotide phase 3 pivotal registration program and timing flexibility regarding partnering for the U.S. and other non-European territories." ( Shifren JL et al. Sexual Problems and Distress in United States Women: Prevalence and Correlates. ObstetGynecol 2008;112 (5); 968-9)
The start of the reconnect study phase 3 clinical trial in the U.S triggers a development milestone payment of €2.5 million (~$3 million) from Gedeon Richter Plc, Palatin's partner in Europe for bremelanotide for FSD. Palatin is also eligible to receive regulatory and sales milestones, and low double-digit royalties on net sales in the European licensed territory.
More information on the trial protocol, including trial design, inclusion/exclusion criteria, etc., can be found at http://clinicaltrials.gov.