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FDA gives OK to Purdue Pharma's Targiniq ER
July 24th, 2014
WASHINGTON – The Food and Drug Administration has approved Purdue Pharma's Targiniq ER, an opioid painkiller with abuse-deterrent properties.
The FDA said Wednesday that Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets) is the second extended-release/long-acting opioid analgesic with approved labeling describing its abuse-deterrent capabilities.
Targiniq ER is indicated to treat pain severe enough to require a daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The drug is not approved for as-needed pain relief.
The FDA noted that Targiniq ER has properties that are expected to deter — but not totally prevent — abuse of the drug by snorting and injection. When 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. Naloxone is a medication that is commonly used to reverse the effects of opioid overdose.
Targiniq ER can still be abused, including when taken orally, which is currently the most common way oxycodone is abused, according to the FDA.
"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.," Sharon Hertz, deputy director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "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 gauge the risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with long-term use beyond 12 weeks. The agency is also requiring postmarketing studies to further assess the effects of the abuse-deterrent features on the risk for abuse of Targiniq ER. The product, too, is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which requires companies to make available to health care professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide medication guides and patient counseling documents containing information on the safe use, storage and disposal of such opioid medications.