logo
Published on FierceBiotech (http://www.fiercebiotech.com)

Safety concerns force delay for Phase III ED trial

By admin
Created Aug 30 2007 - 6:59am

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

Related Articles:
Palatin researchers tout sexual dysfunction data [3]
Gene therapy approach may work against ED [4]


Source URL:
http://www.fiercebiotech.com/story/safety-concerns-force-delay-phase-iii-ed-trial/2007-08-30