Monday 12 March 2012

Enrollment for FSD completes in Phase 2B trial


Palatin Technologies, Inc. declared it has finished enrollment within its Phase 2B clinical trial understanding the efficacy and security of bremelanotide for remedy for female sexual dysfunction (FSD). Over 400 premenopausal females identified having female sexual arousal problem, hypoactive sexual desire dysfunction or both have been enrolled within a study. Affected individuals, which person is going to bear 16 weeks of treatment, will probably be randomized to at least one of four double-blind treatment communities and receive placebo or bremelanotide dosages of 0.75, 1.25, or 1.75 milligrams.

The distress is really a multi-centered, placebo-controlled, randomized, parallel-group trial created to calculate the protection and influence of subcutaneous (SC) bremelanotide doses planned for on-demand make use of in premenopausal females having FSD. The pharmacokinetics of SC bremelanotide is likewise assessed within this trial. Main efficacy endpoint is the change in the volume of gratifying sexual events from baseline to finish of survey. Various secondary endpoints are usually examined.

"We're delighted to have completed affected person enrollment on time, and remain on track for results because of this study in the third calendar part this year," stated Carl Spana, Ph.D., President  & CEO of Palatin. "Bremelanotide would be the only on demand therapy for FSD in clinical trials across the USA, and also has the possibility to transform the treatment of individuals with FSD."

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