FDA approves Targiniq ER from Purdue Pharma

SILVER SPRING, Md. — The Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets). The drug is an extended-release, long-acting opioid analgesic that treats pain severe enough to require daily, long-term opioid treatment and as an alternative to treatment plans that have shown to be inadequate.

Targiniq ER has properties that are expected to deter, but not entirely prevent, abuse of the drug, the agency said. When the tablets are crushed and snorted, (or crushed, dissolved and injected,) the naloxone in the drug blocks the euphoric effects of oxycodone, making it less appealing to abusers than oxycodone alone.

"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 United States,” 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.”

The FDA is requiring postmarketing studies of Targiniq ER to assess serious risks, which include abuse, increased sensitivity to pain, addiction and overdose. The studies will also further examine the effects of the abuse-deterrent features on the risk for abuse of Targiniq ER.

Targiniq ER is manufactured by Purdue Pharma.

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