Palatin Technologies Reports Successful Completion Of Device Bioequivalence Trial
Initiation of Bremelanotide for Female Sexual Dysfunction Phase 3 Clinical Trials Targeted for First Calendar Quarter in 2014
CRANBURY, N.J., Oct. 28, 2013 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE MKT: PTN) today announced the successful completion of a clinical trial designed to demonstrate equivalence of subcutaneously administered bremelanotide via autoinjector compared to pre-filled syringe administration. Bioequivalence was achieved in this clinical trial. Palatin used pre-filled syringes in its Phase 2 clinical trials, but will use the single-dose disposable autoinjector in its planned Phase 3 clinical trials and for commercialization.
Stephen T. Wills, Chief Operating Officer and Chief Financial Officer of Palatin Technologies, commented, "Demonstrating bioequivalence in this study allows us to move forward with confidence regarding the delivery of bremelanotide via autoinjector. The pharmacokinetic profile of bremelanotide using the autoinjector device was consistent with the pharmacokinetic data collected in our completed positive Phase 2B study which used pre-filled syringes. The single-dose disposable autoinjector provides patients with a safe, easy to use device for the delivery of bremelanotide."
The design was a single-center, randomized, double-blind (to device administration) study in 36 healthy female subjects to determine the bioequivalence of 1.75 mg of bremelanotide administered by two different devices. There were no serious adverse events reported and there were no discontinuations in the study.
About Female Sexual Dysfunction
Female Sexual Dysfunction (FSD) covers multi-factorial conditions that have anatomical, physiological, medical, psychological and social components. FSD includes four categories: Sexual Desire Disorders (hypoactive sexual desire disorder [HSDD], sexual aversion disorder), Female Sexual Arousal Disorder (FSAD), Female Orgasmic Disorder (FOD), and Sexual Pain Disorders (dyspareunia, vaginismus). To establish a diagnosis of FSD, one or more of these disorders must be associated with personal distress, as determined by the affected women. In the 2006 PRESIDE study (Prevalence of Female Sexual Problems Associated with Distress and Determinants of Treatment Seeking, reference: Obstet Gynecol 2008 Nov; 112(5):970-8), Shifren and colleagues studied over 30,000 US women, reporting an age-adjusted point prevalence of sexual difficulties causing personal distress in 12% of respondents.
There are no drugs in the United States approved for the treatment of FSD. Bremelanotide is an on-demand treatment for FSD with the potential to transform the treatment of patients with FSD.
Bremelanotide for Female Sexual Dysfunction
Palatin is developing subcutaneously administered bremelanotide for the treatment of FSD in premenopausal women diagnosed with FSD. 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).
About Palatin Technologies, Inc.
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.
SOURCE Palatin Technologies, Inc.
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