With regulators at the FDA waving a red flag over safety concerns, King Pharmaceuticals and Palatin Technologies announced that they will delay the planned launch of a Phase III trial of bremelanotide for ED. Regulators said they were concerned by data in Phase I and Phase II that the drug raised patients' blood pressure in certain patients. Researchers had hoped to pursue the use of the drug as a first-line therapy, but the FDA says the best approach may be for use among patients who have not responded well to other, marketed ED drugs.
- check out the release
- read the MarketWatch report on the trial