YM Biosciences Announces FDA Lifts Clinical Hold on Aerolef® and Clearance of a Phase II Clinical Trial
News Jun 20, 2008
YM BioSciences Inc. has announced that the Clinical Hold imposed by the US Food and Drug Administration (FDA) on the development of YM's AeroLEF® has been lifted. The lifting of this Hold permits YM to resume the expansion into the US of the Phase II clinical development of AeroLEF.
AeroLEF is being developed as a novel and effective approach to the management of acute pain by delivering a proprietary formulation of inhaled, nebulized, free-and-liposome-encapsulated fentanyl. The free fentanyl results in rapid onset of analgesia while the liposome-encapsulated fentanyl produces the extended duration of pain relief.
The FDA cleared a Phase II protocol in June 2007 to proceed with AeroLEF's first trial in the US, however, immediately prior to the End-of-Phase II meeting scheduled and held in January 2008, the FDA imposed a Clinical Hold, now lifted.
YM has also announced that Dr. Ali Raza has been engaged as President of the AeroLEF Division to lead the product's further development.
Dr. Raza has held a number of leadership roles in established and development-stage pharmaceutical companies. He led the global development of CRESTOR® (rosuvastatin), a product approved in more than 60 countries and which is competing for market leadership with Lipitor®. Earlier this year he achieved regulatory clearance for and initiated a major Phase III clinical program for a fentanyl product being developed in more than 50 research centers in Europe.
"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.