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Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

FDA Accepts Purdue Pharma’s Targiniq NDA

Dec. 2, 2013

The FDA has agreed to review Purdue Pharma’s NDA for its investigational Targiniq ER controlled-release tablets CII for the management of chronic pain.

Purdue’s submission is based on data from a 12-week double-blind, randomized, placebo-controlled clinical trial of 600 U.S. patients with previous opioid experience, along with supplemental data from other clinical studies. The drugmaker also evaluated the drug’s potential for abuse, in compliance with the FDA’s January draft guidance on testing and labeling of abuse-deterrent opioids.

Targiniq (oxycodone HCl/naloxone HCl) was originally approved in Germany in 2006 and is marketed in 32 other countries, including Canada, the UK and Australia.

If approved by the FDA, Targiniq ER would be available in 10/5 mg, 20/10 mg and 40/20 mg strengths every 12 hours. The drugmaker is looking into registering Targiniq in additional countries through independent associations or licensing partners. —Lena Freund

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