FDA approves ER oxycodone formulation designed to deter abuse

The FDA has approved oxycodone hydrochloride and naloxone hydrochloride extended release tablets, an opioid analgesic that has abuse-deterrent properties, the FDA said in a press release.

Targiniq ER (Purdue Pharma) is an extended-release/long-acting drug indicated to treat severe pain that requires daily, 24-hour, long-term opioid treatment, and does not sufficiently respond to alternate treatment options. The compound is the second drug in this class with FDA-approved labeling that cites abuse-deterrent properties compliant with the FDA’s 2013 draft guidance, Abuse-Deterrent Opioids — Evaluation and Labeling.

While the drug is designed to deter abuse of oxycodone by snorting and injection, it is not able to entirely prevent abuse. The naloxone in the formulation acts to block the euphoric effects of oxycodone when crushed and snorted or crushed, dissolved and injected, thus making it less appealing to users than oxycodone alone. Naloxone is a drug frequently used to counteract the effects of opioid overdose. Targiniq can still be abused, particularly through oral delivery, which is currently the most prevalent form of oxycodone abuse. The FDA noted that fatal overdoses of the drug can still occur after taking too much, whether this is due to intentional abuse or is accidental.

According to Sharon Hertz, MD, deputy director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research, opioids with abuse-deterrent properties are an important first step in preventing prescription drug abuse.

“The FDA is committed to combating 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,” Hertz said in the press release. “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 drug is not intended for use as an “as-needed”pain reliever, and is not approved for this use. Due to its potential for abuse, misuse and addiction, it is only indicated in those for whom alternative treatment options have failed to provide safe and adequate pain management.

Approval is based on data from a clinical trial of 601 patients with chronic low back pain, as well as a safety database including treatment of more than 3,000 patients. In vitro and in vivo abuse liability studies affirmed the abuse deterrent features of the drug as it pertains to snorting and injecting. Nausea and vomiting are the most common side effects reported with the drug. Postmarketing studies of the drug, as required by the FDA, will evaluate the potential for misuse, abuse, hyperalgesia, addiction, overdose and death over a longer follow-up (beyond 12 weeks).

Additionally, the FDA is requiring postmarketing studies to analyze the effects of the abuse-deterrent properties on abuse risk. The drug is also part of the extended-release/long-acting (ER/LA) Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which calls for companies to educate health care professionals on the safe prescription of ER/LA opioid analgesics. The REMS also requires that companies provide Medication Guides and patient counseling literature which instruct the safe use, storage and disposal of these drugs, the FDA said in the press release.