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FDA Agrees to Review Targiniq ER (Oxycodone/Naloxone) for Treatment of Chronic Pain
Drug is marketed in 32 countries (November 26)
The FDA has accepted for review a New Drug Application (NDA) for Targiniq ER (oxycodone HCl/naloxone HCl controlled-release, Purdue Pharma) tablets for the management of chronic pain.
The investigational Schedule II drug combines the opioid analgesic oxycodone and the opioid antagonist naloxone. If approved by the FDA, Targiniq ER will be available in 10/5-mg, 20/10-mg, and 40/20-mg dosage strengths for administration every 12 hours.
The NDA is based on the results of a 12-week, double-blind, randomized, placebo-controlled clinical trial involving 600 opioid-experienced patients as well as on supporting data from other clinical studies. The submission also includes data from clinical abuse liability studies.
The drug was first approved in Germany in 2006 under the brand name Targin and is sold in 32 countries, including Canada, the United Kingdom, and Australia.[Source: Purdue Pharma; November 26, 2013.]