According to YM, unlike fixed dose approaches to opioid delivery, where a significant titration period is often required to determine the suitable dose for the patient, AeroLEF is designed to permit patients to match dosage to their individual pain intensity for each pain episode.
“We look forward to receiving the results of this study of AeroLEF, which in previous studies has provided highly-individualized, episode-specific pain relief in the post-operative setting,” said David Allan, chairman and CEO of YM BioSciences.
“We are continuing to assess the design of additional phase II clinical studies and plan to file a US IND shortly. Concurrently, we will continue to educate potential development and marketing partners about the unique attributes of AeroLEF.”
The phase IIb trial of AeroLEF for the treatment of moderate to severe post-surgical pain consisted of two parts. Part I was an open label trial designed to allow investigators to gain familiarity with administration of the product and enrolled 21 patients. Part II was a trial of 99 patients and was designed to evaluate the safety and efficacy of AeroLEF compared to placebo.
The primary endpoint for this study was the summed pain relief plus pain intensity difference (SPRID) scores during the first four hours after the start of the initial dose. Secondary endpoints included time to effective pain relief, as well as six safety endpoints.
YM expects that the results of the primary efficacy and safety analyses will be available in mid-second quarter of 2007.