Anesthetic and Analgesic Drugs Advisory Committee and Drug Safety and Risk Managment Advisory Committee

The Committees will discuss a new drug application for oxycodone hydrochloride extended-release oral tablets, submitted by Intellipharmaceutics Corp., with the proposed indication of management of moderate-to-severe pain when a continuous around-the-clock analgesic is needed for an extended period of time. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The Committees will be asked to discuss the overall risk-benefit profile of the product, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support labeling.