Will Palatin's Phase III Female Sex Endpoint Swap Pass With FDA?

Palatin plans to file the drug for FDA approval in the second half of 2017, but a change in the co-primary endpoint presents a complication.

Having fallen prey to unfortunate drug development timing outside its control, Palatin Technologies Inc. is set to embark upon a somewhat risky strategy for the pivotal trials for its female sexual desire drug bremelanotide, as it revises a co-primary endpoint to meet FDA’s newly issued guidance.

Bremalanotide is a melanocortin 4 receptor agonist given as a synthetic peptide via auto-injector

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