The FDA has approved Targiniq ER (oxycodone HCl/naloxone HCl controlled-release; Purdue Pharma) Tablets, an extended-release/long-acting (ER/LA) opioid analgesic with abuse-deterrent properties indicated for the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The approval 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 included data from clinical abuse liability studies designed and conducted consistently with the FDA’s January 2013 Draft Guidance for Industry: Abuse-Deterrent Opioids-Evaluation and Labeling. Data from in vitro and in vivo abuse liability studies demonstrated the abuse deterrent features of Targiniq ER as they relate to certain types of abuse (such as snorting and injecting). The abuse-deterrent properties of Targiniq ER are designed to make the product more difficult to manipulate for the purpose of misuse or abuse by various routes of administration.
Targiniq ER will be available in 10mg/5mg, 20mg/10mg, and 40mg/20mg strength tablets.
For more information visit FDA.gov.