FDA Accepts for Review Purdue Pharma's New Drug Application for Targiniq™ ER (oxycodone HCl/naloxone HCL Controlled-Release) Tablets CII

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Nov 26, 2013, 07:30 ET

STAMFORD, Conn., Nov. 26, 2013 /PRNewswire/ -- 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also includes data from clinical abuse liability studies designed and conducted consistent with FDA's January 2013 Draft Guidance for Industry: Abuse-Deterrent Opioids-Evaluation and Labeling.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®.

About Chronic Pain
Purdue is a leader in developing treatment options for the management of chronic pain, which is one of the most common reasons for visits to healthcare professionals. Chronic pain conditions affect more than 100 million U.S. adults and costs the American economy as much as $635 billion each year in direct healthcare expenses and lost productivity.^[1]

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.

^[1] Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Institute of Medicine, June 29, 2011.

SOURCE Purdue Pharma L.P.