Powerful Painkiller Approved by FDA

The U.S. Food and Drug Administration has approved a powerful painkiller.

Targiniq ER is a combination of narcotic oxycodone and naloxone, and is made by Purdue Pharma. The drug combo, FDA said, deters people from snorting or injecting the painkiller.

Prescription drug abuse is on the rise in the U.S. Between 2000 to 2010, there has been a 16-fold increase in opioid painkillers. Oxycodone and hydrocodone are some of the widely abused painkillers.

FDA says that naloxone in the new drug will prevent the high effects of oxycodone and even reverse for opioid effects.

"The FDA is committed to combatting the misuse and abuse of all opioids, and the development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the U.S.," said Sharon Hertz, M.D., deputy director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA's Center for Drug Evaluation and Research.

"Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse, and will better enable the FDA to balance addressing this problem with meeting the needs of the millions of people in this country suffering from pain," Hertz added in a news release.

The federal agency maintains that Targiniq ER can still be abused and that people can take high doses of the drug orally. FDA has warned that using too much of the drug can result in overdose and even death.

Safety and effectiveness of the new painkiller combination was assessed via clinical trial involving around 600 people.

FDA has warned that the drug is not to be used for as-needed pain relief. Targiniq ER is for people who aren't responding to other treatment for chronic pain. Nausea and vomiting are the most common side-effects of the drug.

The agency has also sought post-marketing drug trials. The clinical studies will look into the risk of abuse, increased sensitivity to pain and addiction in people using the drug for more than a year.