OxyContin maker submits new painkiller pill to FDA
WASHINGTON (AP) — The maker of OxyContin is asking the Food and Drug Administration to approve a new abuse-resistant combination pill to treat chronic pain.
Purdue Pharma said in a statement that the FDA accepted its application for Targiniq ER, an extended release tablet that combines oxycodone — the active ingredient in OxyContin — with the drug naloxone.
The naloxone, which can reverse the effects of opioids, is intended to help make the medicine less likely to be abused. Addicts often crush opioid pills to snort or inject them.
The Stamford, Conn.-based company said its application is based on a 12-week study of 600 patients who have a history of using opioid pain relievers. The company says the trial included data on the drug's ability to be abused.
In 2010 Purdue introduced a new version of its blockbuster OxyContin that is designed to be more difficult to crush, break or dissolve. The FDA has been pressuring companies to design new painkillers with tamper-resistant features to make them more difficult to abuse.
OxyContin has long been one the nation's top-selling prescription painkillers with sales of more than $2.8 billion last year, according to prescription tracker IMS Health.
In 2007, Purdue Pharma and three of its executives paid $634 million and pleaded guilty to charges of misleading the public about the safety and addictiveness of OxyContin.