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news.YM BioSciences' subsidiary, Delex Therapeutics, has enrolled the first patient in its 120-patient phase IIb trial of its analgesic product AeroLef designed for the treatment of moderate to severe acute pain.
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AeroLef is a proprietary formulation of free and liposome-encapsulated nebulized fentanyl, which permits delivery through the lung. The product provides personalized, patient controlled analgesia to address the unpredictable variability in analgesic needs that are a hallmark of acute pain episodes, including breakthrough cancer pain.
The current phase IIb study is randomized, double-blinded, and placebo-controlled, 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.
In a previous single dose phase IIa study, 95% of post-surgical patients achieved clinically meaningful analgesia following self-administration of Aerolef to treat their moderate to severe pain. Patients reported rapid onset of analgesia followed by an extended duration of pain relief.