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YM BioSciences Announces Secondary Efficacy and Safety Findings in,Randomized Phase IIB Aerolef Trial

(p=0.005). As well, the percentage of patients reporting a pain relief (PR) score of more than or equal to 2 (moderate, lots or complete relief) at the end of the dosing period with AeroLEF(TM) was 60%, also statistically significant compared to placebo (32%) (p=0.0166).

Both the TOTPAR4 (total pain relief over 4 hours, summed pain relief scores) and SPID4 (summed pain intensity difference scores patients report over first 4 hours after initiation of dosing) values for the first dose of AeroLEF(TM) showed statistically significant differences over placebo (p<0.02), consistent with the outcome of the primary endpoint. Across the entire study, for up to three dosing sessions with AeroLEF(TM), self-declared effective analgesia occurred within six minutes in 25% of patients, within 11 minutes in 50%, and within 20 minutes in 75%. Patients receiving AeroLEF(TM) in the blinded portion of the trial reported a mean duration of effective pain relief time of 237 minutes (~4 hours) for the first dose. Similar means were observed across subsequent doses of AeroLEF(TM); 229.2 minutes and 243.5 minutes for doses two and three, respectively.

Administration of AeroLEF(TM) in this study resulted in no unexpected adverse safety events. Attributable adverse events (AEs) observed were generally consistent with typical opioid adverse effects seen in the immediate post-operative period. Treatment-emergent AEs were similar between treatment groups: 70.8% in the AeroLEF(TM) group compared with 67.6% in the placebo group. The majority of adverse events were mild in intensity. Opioid antagonists (interventional medication commonly necessary in studies of opioids) were not administered to any subjects in the trial. AeroLEF does not appear to increase the risk of key adverse events (such as hypoxia and bradypnea) and has the potential to minimize certain otherwise expected adverse effects of interest to patients and physicians, warranting further investigation and development.'"/>




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