Initial results from the study show that AeroLEF provided benefit compared to placebo. However, the difference in effectiveness between the placebo and treatment groups has not yet reached the study endpoint and therefore YM BioSciences will continue as planned to enroll the original target of patients.
“This preliminary review indicates that we should continue to advance the AeroLEF phase IIb study to full enrollment,” said David Allan, chairman and CEO of YM BioSciences.
AeroLEF is a unique, inhaled-delivery for the treatment of moderate to severe acute pain, including cancer pain.
The primary endpoint for this study is to asses the difference between pain intensity and pain relief 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.