JDP’s pivotal Phase 3 trial of IV cetirizine in acute urticaria signals the advancement of this exciting product into the very last stage of the clinical program required for marketing registration in the United States and Canada.
Blue Bell, Pennsylvania (PRWEB)
May 30, 2017
JDP Therapeutics Inc., a privately held specialty pharmaceutical company focused on developing and commercializing proprietary product candidates principally for use in the hospital and urgent care settings, announced today that it has initiated its pivotal phase 3 clinical trial, ETTAU-03, to evaluate the efficacy and safety of JDP-205 (IV cetirizine) for the treatment of acute urticaria, the most common symptom of acute allergic reactions.
JDP-205 is an intravenous injection of cetirizine (aka “IV Cetirizine”) for the indication of acute urticaria. The oral cetirizine has been marketed by Pfizer as Zyrtec® for allergic rhinitis and chronic urticaria since 1995, and later by McNeil as an OTC product since 2008.
The pivotal phase 3 clinical trial, referred to as ETTAU-03, is the last trial as part of JDP’s clinical program to evaluate the efficacy and safety of IV cetirizine injection for the treatment of acute urticaria.
The ETTAU-03 study is a randomized, double-blind, active controlled study. It will enroll a total of 256 patients who will be treated with either IV cetirizine injection or the active control IV diphenhydramine injection in patients with a diagnosis of acute urticaria who need treatment with antihistamine to alleviate their allergic symptoms.
The primary endpoint of the trial is to establish the non-inferiority of IV cetirizine injection compared to IV diphenhydramine injection in reducing a key symptom score two hours after treatment. Other endpoints include reduced time…