Painkiller Drug ‘Targiniq ER’ Gets FDA Approval

The new hard-to-abuse pain killer drug 'Targiniq ER' has bagged approval from  the U.S. Food and Drug Administration.  

Targiniq ER is a pain relieving drug containing 'oxycode hydrochloride' and 'naloxone hydrochloride' and is manufactured by the Purdue Pharma in Stamford. The medication helps treat chronic pain conditions that do not react to common  drugs. Unlike other pain relievers, Targiniq ER when crushed and snorted or ingested by the body does not cause mild intoxication.

The naloxone in the medicine blocks euphoric effects of the oxycodone thereby minimizing the chances of drug abuse. However, experts warn taking too many Targiniq ER pills orally on purpose or by accident can lead to overdosing and even death.

"The FDA is committed to combating 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, in a news release.

 "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," she adds.

The agency tested the safety and efficacy of Targiniq ER' on 601 individuals suffering from lower back ache. FDA officials also looked at health records of over 3,000 people who were prescribed the drug and confirmed its abuse-deterrent features. The participants did not experience any major side-effects apart from nausea and vomiting.

FDA's measure to bring down the incidence of overdose-related deaths and pain killer addiction was initiated after recording a rise of both events in the past decade. According to the data by the Centers for Disease Control and Prevention, the overall number of deaths caused by overdosing on medications like OxyCotin and Vicodin saw a four-fold increase between 1990 and 2010, reports the Associated Press.

The FDA will be conducting post-marketing researches to investigate the risk rate for misuse, addiction, death and intensified pain conditions associated with the long-term usage of Targiniq ER.