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Extended-Release Oxycodone With Abuse-Deterrent Properties Gets FDA Nod

Product can still be abused when taken orally

The FDA has approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets, Purdue Pharma), an extended-release/long-acting (ER/LA) opioid analgesic, to treat pain that is severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Targiniq ER is the second ER/LA opioid analgesic with FDA-approved labeling describing the product’s abuse-deterrent properties consistent with the agency’s 2013 draft guidance for industry.

The product has properties that are expected to deter, but not totally prevent, abuse of the oxycodone component 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 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. Taking too much Targiniq ER for purposes of abuse or by accident can cause an overdose that can result in death.

Targiniq ER is not approved, and should not be used, for as-needed pain relief. Given the product’s risks for abuse, misuse, and addiction, it should be prescribed only to people for whom alternative treatment options are ineffective, are not tolerated, or would be otherwise inadequate to provide sufficient pain management.

The safety and effectiveness of Targiniq ER was evaluated in a clinical study involving 601 subjects with chronic low back pain. The safety database supporting approval included more than 3,000 subjects treated with Targiniq ER. Data from in vitro and in vivo abuse-liability studies demonstrated the abuse-deterrent features of Targiniq ER as they relate to snorting and injection. The most common side effects of treatment with Targiniq ER are nausea and vomiting.

The FDA is requiring post-marketing studies of Targiniq ER to assess the serious risks of misuse, abuse, hyperalgesia, addiction, overdose, and death associated with use beyond 12 weeks. The FDA is also requiring post-marketing studies to further assess the effects of the abuse-deterrent features on the risk for abuse of Targiniq ER.

In addition, Targiniq ER is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which requires companies to educate health care professionals 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 ER/LA opioids.

Source: FDA; July 23, 2014.

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