Erectile Dysfunction Drug Trial Put on Hold

Palatin Technologies and King Pharmaceuticals announced that they have delayed plans to move an erectile dysfunction (ED) drug into Phase III clinical trials after the FDA questioned the drug’s benefits and raised safety concerns.

The clinical trials involve bremelanotide, which the sponsors said is a first-in-class investigational melanocortin agonist drug for the treatment of male ED.

FDA officials “raised serious concerns about the acceptable benefit/risk ratio” of these trials, the sponsors said. After reviewing data from the Phase I and II studies of the drug, “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,” the companies added.

However, agency officials told the sponsors that the FDA is amenable to proposals for a different drug development pathway, such as for a second-line therapy for patients who do not respond to currently approved PDE-5 inhibitors.