Palatin Technologies has 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 II clinical trials, but will use the single-dose disposable autoinjector in its planned phase III clinical trials and for commercialization.
Stephen T. Wills, chief operating officer and chief financial officer of Palatin Technologies, said, "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 IIb 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 1.75mg of bremelanotide administered by two different devices. There were no serious adverse events reported and there were no discontinuations in the study.