FDA Approves New Chronic Oxycodone with Abuse-deterrent Properties

July 24, 2014
Adam Hochron

As it continues to tackle the issue of prescription drug abuse, the US Food and Drug Administration today approved an extended-release/long-acting opioid analgesic designed to help chronic pain patients while curbing their ability to tamper with it.

As it continues to tackle the issue of prescription drug abuse, the US Food and Drug Administration (FDA) today approved an extended-release/long-acting (ER/LA) opioid analgesic designed to help chronic pain patients while curbing their ability to tamper with it.

Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride) was approved to treat pain “severe enough to require daily, around-the-clock, long-term opioid treatment” in those who have attempted other treatment methods unsuccessfully, an FDA statement said.

“When it is crushed and snorted — or crushed, dissolved, and injected — the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone,” the FDA noted. However, the agency said the oral agent could still be taken for the wrong reasons, which could “cause an overdose that can result in death.”

Sharon Hertz, MD, Deputy Director of the Division of Anesthesia, Analgesia, and Addiction Properties at the FDA’s Center for Drug Evaluation and Research, said Targiniq is the latest tool in the agency’s fight against opioid and prescription drug abuse.

“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 stated.

Manufactured by Purdue Pharma, Targiniq ER is part of the Risk Evaluation and Mitigation Strategy (REMS), which requires training for healthcare professionals on the best methods to prescribe opioids, as well as the potential risks associated with the medications.

The FDA warned that the ER/LA opioid should not be considered an “as-needed” pain reliever; rather, it should “only be prescribed to people for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management.”

In the drug’s safety and efficacy trials, the most commonly reported side effects were nausea and vomiting.