KING, PALATIN INITIATE PHASE IIB TRIALS EVALUATING PT-141
King Pharmaceuticals and Palatin Technologies have initiated patient enrollment in two double- blind, placebo-controlled Phase IIb clinical trials of the drug PT-141 in patients with erectile dysfunction (ED).
The main objectives of these studies are to further evaluate safety, treatment duration, patient populations and a range of dosages that will be incorporated into Phase III pivotal trials. PT-141 is a melanocortin agonist that King and Palatin are jointly developing for treating male and female sexual dysfunction.
The first Phase IIb clinical trial will evaluate the safety and efficacy of PT-141 in 560 nondiabetic patients suffering from mild-to-severe ED.
The second clinical trial will similarly evaluate 265 diabetic patients with ED. Both clinical trials will involve an "at home" three-month treatment period conducted at approximately 35 clinical trial sites throughout the U.S. Additionally, the trials will evaluate a range of PT-141 intranasal dosages between 5 mg and 15 mg.