YM BioSciences painkiller successful in trial

YM says AeroLEF is a unique, inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for the treatment of moderate to severe pain, including cancer pain.

The company previously reported that this trial had successfully achieved its primary endpoint, the summed pain intensity difference/pain relief scores during the 4 hours from the start of the initial dose of study medication.

For the first dose administered in the PACU, the percentage of patients reporting a pain intensity (PI) score of less than or equal to 1 (mild pain or no pain) at the end of the dosing period with AeroLEF was 59%, a statistically significant difference from placebo (27%).

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 was 60%, also statistically significant compared to placebo (32%).

Attributable adverse events (AEs) observed in this 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 group compared with 67.6% in the placebo group. The majority of adverse events were mild in intensity.

YM says the drug did 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.

“We are very pleased that our upcoming trial will be led by a key opinion leader in the US and look forward to discussions with regulatory authorities on the path to approval for our drug,” said David Allan, Chairman and CEO of YM BioSciences.