YM BioSciences Inc, an oncology company that identifies, develops and commercialises differentiated products for patients worldwide, announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for AeroLEF.
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. In contrast to fixed-dose approaches to opioid delivery, where a significant titration period is often required to determine the suitable dose for the patient, AeroLEF is being developed as a non-invasive delivery system designed to enable patients to self-titrate. Using AeroLEF, patients can identify and select a personalized dose for each pain episode, achieving both rapid onset and extended duration of analgesia.
"This clearance marks the start of a formal path towards regulatory approval for AeroLEF in the US and builds on the momentum of having recently reported positive phase II data for this unique and important product," said David Allan, chairman and CEO of YM BioSciences. "Under this IND, YM plans to initiate an open-label phase II trial designed to expand the target patient population of AeroLEF and in parallel is planning an End of phase II meeting with the FDA to gain agreement on the design of the phase III program. The phase II study is planned to recruit up to 50 post-surgical patients across three sites in the US and will include a number of opioid tolerant patients to evaluate AeroLEF in this increasingly important market segment."
YM recently reported that AeroLEF met its primary endpoint in a 99 patient, randomised, placebo-controlled, multi-centre phase IIb trial (DLXLEF-AP4) in opioid-naïve patients with post-operative pain following orthopedic surgery. AeroLEF showed a statistically significant difference in SPRID4 (a summary of the combined changes in pain relief and in pain intensity that patients report over the first four hours following initiation of dosing) from placebo for the treatment of the first pain episode. YM is completing a detailed analysis of the numerous secondary endpoints and safety data from this study to extend the information it will make available.