YM BIOSCIENCES RELEASES INTERIM RESULTS OF PHASE II PAIN TRIAL

YM BioSciences has announced that its DELEX Therapeutics division has received the results of an interim analysis on the first 67 patients from its randomized, placebo-controlled Phase IIb trial (DLXLEF-AP4) of AeroLEF for the treatment of moderate to severe acute pain in post-surgical patients. The data indicated that AeroLEF provided benefit compared with placebo; however the difference between the treatment arm and placebo arm had not yet achieved the significance level predefined in the study protocol, and therefore the study will continue as planned to enroll the original target of 99 randomized patients.

AeroLEF is an inhaled-delivery composition of free and liposome-encapsulated fentanyl for the treatment of moderate to severe acute pain, including cancer pain. The Phase IIb study consisted of two parts. Part I was an open-label trial of 21 patients to allow investigators to gain familiarity with administration of the product. Part II is a randomized, double-blinded, placebo-controlled trial of 99 patients and is designed to evaluate the safety and efficacy of multiple doses of AeroLEF for management of pain in post-surgical patients following elective orthopedic surgeries. The primary endpoint for this study is the Summed Pain Relief plus Pain Intensity Difference scores during the first four hours after the start of the initial dose. Secondary endpoints include Time to Effective Pain Relief, as well as six safety endpoints.