On September 10, 2015, the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Committee will jointly discuss an NDA for Purdue’s oxycodone immediate-release tablets, with the proposed indication of the management of moderate to severe pain where the use of an opioid analgesic is appropriate. It has been formulated with the intent to provide abuse-deterrent properties. The pharmacokinetic data demonstrate that there is a significant food effect resulting in a significant delay in absorption and peak plasma concentration of oxycodone when taken with food. Purdue proposes to address this finding by labeling the product to be taken on an empty stomach, but patients may have difficulty complying with these instructions as the product is dosed every 4 to 6 hours as needed. The committees will be asked to discuss the potential safety risks and the potential effects on efficacy associated with the delayed peak concentration when taken with food, and the feasibility of labeling to be taken an empty stomach as a means to mitigate the potential risks.
The committees will also be asked to consider whether the potential public health benefit of the product’s abuse-deterrent properties are sufficient to outweigh the risk to patients who are prescribed the product for the management of pain.
From 9:30 a.m. to 5 p.m., the meeting is open to the public. From 8 a.m. to 9:30 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the committees will discuss the drug development program of an investigational product.