Purdue Pharma announced that the 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. Targinq ER is an investigational combination of the opioid analgesic, oxycodone, and the opioid antagonist, naloxone.
The NDA submission was based on the results of a 12-week, double-blind, randomized, placebo-controlled 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also includes data from clinical abuse liability studies designed and conducted consistent with FDA’s January 2013 Draft Guidance for Industry: Abuse-Deterrent Opioids-Evaluation and Labeling.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.
If approved by the FDA, Targiniq ER will be available in 10/5 mg, 20/10 mg and 40/20 mg dosage strengths.
For more information call (888) 726-7535 or visit PurduePharma.com.