Safety concerns force delay for Phase III ED trial

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 [1]
- read the MarketWatch report [2] on the trial

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