The US Food and Drug Administration (FDA) has approved an abuse-deterrent extended-release formulation of oxycodone (Targiniq ER, Purdue Pharma LP), a combination of oxycodone hydrochloride and naloxone hydrochloride, the agency announced today.
The new formulation is approved to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment, for which alternative treatment options are inadequate.
It is the second extended-release/long acting (ER/LA) opioid with FDA-approved labelling describing its abuse-deterrent properties “consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling ,” a statement from the FDA notes.
“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 US,” said Sharon Hertz, MD, 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.”
Properties of the new formulation are expected to “deter, but not totally prevent, abuse of the drug by snorting and injection,” the release notes. When it is crushed and snorted, or crushed, dissolved and injected, the naloxone blocks the euphoric effects of the oxycodone, “making it less liked by abusers than oxycodone alone,” the FDA said. Naloxone is already used to reverse opioid overdose.
The combination product can nevertheless be abused when taken orally, the statement notes, currently the most common way oxycodone is abused. “It is important to note that taking too much Targiniq ER for purposes of abuse or by accident, can cause an overdose that can result in death,” the agency stressed.
The formulation shouldn’t be used for as-needed pain relief, and given the risks for abuses, misuse and addiction, should only be prescribed to people for whom alternatives are either ineffective, not tolerated, or would be “otherwise inadequate” to provide pain management.
Approval was based on a clinical trial of 601 people with chronic low back pain. The safety database supporting approval includes treatment of more than 3000 people with the newoxycodone/naloxone formulation. Data from in vitro and in vivo abuse liability studies showed abuse-deterrent features of this formulation against misuse by snorting or injecting.
The most common side effects were nausea and vomiting.
The FDA is requiring postmarketing studies to assess the risks for misuse, abuse, hyperalgesia, addiction, overdose and death with Targiniq ER, and to further assess the effects of the abuse-deterrent features on the risk for abuse.
“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,” the FDA concludes.