Purdue Submits NDA for Immediate-Release Oxycodone Tablets withAbuse-deterrent Design to FDA for Review
Stamford, CT – August 29, 2014 – Purdue Pharma L.P. today submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an immediate-release oxycodone HCl formulation designed with the intent to deter intranasal and intravenous abuse of the medication. The proposed indication for the investigational drug is for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.
Purdue has requested the FDA to consider a priority review for this NDA. The NDA submission is for the following milligram-tablet strengths of oxycodone HCl: 5, 10, 15, 20, and 30.
The NDA includes data from clinical abuse liability studies that were conducted in accordance with FDA’s 2013 draft Guidance for Industry Abuse-Deterrent Opioids – Evaluation and Labeling, and Purdue is requesting that appropriate language describing the abuse-deterrence properties and these studies be included in the product’s label.
About Purdue Pharma L.P.
Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on chronic pain. Headquartered in Stamford, CT, Purdue Pharma is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.
Senior Director, Public Affairs