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news.YM BioSciences has reported encouraging top-line results from its phase IIb trial of AeroLEF in opioid naive patients with post-operative pain following orthopedic surgery.
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AeroLEF met the primary endpoint of the study, showing a statistically significant difference in SPRID4, a summary of the combined changes in pain relief and in pain intensity that patients report over the first four hours following initiation of dosing, from placebo.
AeroLEF is an inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain.
The drug is being developed as a non-invasive patient self-titrated delivery system designed to enable patients to identify and select a personalized dose for each pain episode, achieving both rapid onset and extended duration of analgesia.
David Allan, chairman and CEO of YM BioSciences, said: “These results will also be used to enhance the design of the additional phase II trial that we are planning for the US, as well as the eventual phase III trial.”