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news.Delex Therepeutics, a subsidiary of YM BioSciences, has received permission from Heath Canada to initiate a mid phase study of its drug candidate, AeroLEF, for the treatment of moderate to severe acute pain.
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“We expect that this trial will continue to demonstrate the important difference that Delex’s particular approach makes to patients with its pulmonary delivery of opioids when compared to all the other entrants into this large market,”said David Allan, chairman and CEO of YM BioSciences.
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.
“To our knowledge, AeroLEF is the only product that provides the prospect of personalized, patient-controlled dosing to match each patient’s individual pain event which, by definition, offers ‘the right dose each time’,” said Diana Pliura, President and CEO of Delex Therapeutics.
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.
The phase IIb trial is expected to be initiated in Q4, 2005, in Canada, at six to eight sites. The trial is expected to enroll approximately 120 patients and complete recruitment in Q1, 2006, with the prospect of a final report in Q2, 2006.