King Pharmaceuticals, Palatin Technologies Delay Bremelanotide Program
Palatin Technologies and King Pharmaceuticals said they have delayed plans for the initiation of Phase III clinical trials with bremelanotide for the treatment of male erectile dysfunction.
The decision follows responses from representatives of the FDA who raised serious concerns about the acceptable benefit/risk ratio to support the progression of the proposed program into Phase III studies, Palatin and King said.
After reviewing the data generated in the Phase I and II studies, the FDA questioned the overall efficacy results and the clinical benefit of this product in both the general and diabetic ED populations, and cited blood pressure increases as its greatest safety concern.
According to the companies, though the FDA was not supportive of the proposed Phase II studies for erectile dysfunction with bremelanotide, it was amenable to proposals for a different drug development pathway, such as for a second-line therapy in non-responders to currently approved PDE-5 inhibitors.