YM Biosciences got the green light from regulators to resume development of its acute pain therapy--AeroLEF. The mid-stage trial of AeroLEF had been cleared in June of last year, but the FDA put a hold on further development of the drug just before the End-of-Phase II meeting in January 2008. The FDA had asked for more safety data gathered in earlier trials. The AeroLEF acute pain relief is based on a formulation of inhaled, nebulized, free-and-liposome-encapsulated fentanyl. On a related note, Dr. Ali Raza has been engaged as president of the AeroLEF Division.
"I am delighted to have joined the AeroLEF team at YM BioSciences and look forward to moving rapidly to the late-stage, international development of this unique product," said Dr. Raza.
- check out YM's release