DELEX THERAPEUTICS TO INITIATE PHASE IIB AEROLEF TRIAL
YM BioSciences has reported that its subsidiary, DELEX Therapeutics, has received permission from Heath Canada to initiate a randomized Phase IIb study with AeroLEF, its unique formulation of the opioid, fentanyl, for the treatment of moderate-to-severe acute pain.
AeroLEF, a proprietary fentanyl formulation for inhalation, is designed to provide personalized, patient-controlled analgesia to address the unpredictable variability in analgesic needs that are a hallmark of acute pain episodes, including breakthrough cancer pain.
In a previous single-dose Phase IIa study, 95 percent 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.