FDA Approves Targiniq ER for Severe Pain
The US Food and Drug Administration (FDA) has approved Targiniq ER (oxycodone and naloxone, Purdue Pharma), as a treatment for severe pain. This is the second approval of a long-acting, extended-release opioid with “abuse deterrent” properties since the FDA issued industry guidelines in 2013.
The new agent, which contains naloxone, is 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,” noted the agency in a press release.1 However, the most common route of opioid abuse is still through oral ingestion, which naloxone will not effect.
In announcing the approval, Sharon Hertz, MD, deputy director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research, noted that "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. 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 has urge manufacturers to develop abuse deterrent formulations to prevent possible misuse and abuse of opioids. But recent decisions by the agency have not been without controversy. In April 2013, the FDA approved updated labeling for Purdue Pharma’s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets.2 The new version of Oxycontin, which contained properties that made it more difficult to inject and snort the agent, replaced the original Oxycontin tablets, which were first introduced in 1995.
In May, 2013, the FDA denied a petition from Endo Pharmaceuticals to reclassify Opana ER. The agency noted that “while there is an increased ability of the reformulated version of Opana ER to resist crushing relative to the original formulation, study data showed that the reformulated version’s extended-release features can be compromised when subjected to other forms of manipulation, such as cutting, grinding, or chewing, followed by swallowing.”3
Finally, in October of 2013, the FDA approved Zohydro, manufactuered by Zoginix. Zohydro is a single-entity extended-release version of hydrocodone.4 Much of the controversy surrounding Zohydro’s approval was centered on its potential for abuse. The decision by the FDA to approve the agent without abuse-deterrent barriers caused a wave of lawsuits and calls for the agency to reverse its approval, but the FDA has steadfastly defended its decision.
How Targinq Was Approved
The safety and effectiveness of Targiniq ER was evaluated in a clinical trial of 601 people with chronic low back pain, reported the agency. “The safety database supporting approval included treatment of more than 3,000 people with Targiniq ER. Data from in vitro (in a laboratory) and in vivo (testing with people) abuse liability studies demonstrated the abuse deterrent features of Targiniq ER as they relate to certain types of abuse (snorting, injecting). The most common side effects of Targiniq ER are nausea and vomiting,” they noted.
As with all ER/LA opioids, the FDA is requiring postmarketing studies of the agent to study the risks of misuse, abuse, as well as “increased sensitivity to pain (hyperalgesia), addiction, overdose, and death associated with long term use beyond 12 weeks.” The FDA is also requiring postmarketing 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 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 ER/LA opioids.