Bouncing back from discouraging preliminary results, YM BioSciences is reporting that a Phase IIb trial of AeroLEF in patients with post-operative pain following orthopedic surgery met the primary endpoint of the study. AeroLEF is an inhaled-delivery composition of free and liposome encapsulated fentanyl for the treatment of moderate to severe acute pain, including cancer pain.
"These results continue to demonstrate the unique potential for AeroLEF to be further developed into a valuable product for pain management across a broad range of indications, which could include post-operative pain, medical emergency pain and breakthrough pain," said David Allan, Chairman and CEO of YM BioSciences. "We look forward to completing a detailed analysis of the numerous secondary endpoints and safety data from this study to extend the information we will make available. These results will also be used to enhance the design of the additional Phase II trial that we are planning for the U.S. as well as the eventual Phase III trial."