FDA accepts Purdue Pharma's Targiniq ER Tablets CII NDA for review

Purdue Pharma L.P. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for Targiniq™ ER (oxycodone HCl/naloxone HCl controlled-release) Tablets CII, for the management of chronic pain.

"This milestone brings us closer to offering an important treatment option for the management of chronic pain," said Gary L. Stiles, MD, Purdue Pharma's Senior Vice President of Research and Development. "It also represents another step forward in our effort to develop an array of products that incorporate abuse-deterrent features."

This investigational drug combines the opioid analgesic, oxycodone, and the opioid antagonist, naloxone. If approved by the FDA, Targiniq ER would be available in 10/5 mg, 20/10 mg and 40/20 mg dosage strengths for dosing every 12 hours (Q12H).

The NDA is based on the results of a 12-week, double-blind, randomized, placebo-controlled U.S. clinical trial with 600 opioid-experienced patients as well as supporting data from other clinical studies. The submission also includes data from clinical abuse liability studies designed and conducted consistent with FDA's January 2013 Draft Guidance for Industry: Abuse-Deterrent Opioids-Evaluation and Labeling. In the NDA submission, Purdue Pharma is requesting the inclusion of language about abuse deterrence in the product's proposed label based on the results of these studies.

This product was first approved in Germany in 2006 under the brand name Targin® and is currently marketed in 32 countries, including Canada, the United Kingdom, and Australia under the trade names Targin®, Targiniq®, and Targinact®.