The Food and Drug Administration on July 24 approved an opioid tablet formulated to deter abuse if crushed, the agency announced.
Called Targiniq ER (extended release), the long-acting oxycodone formulation contains naloxone hydrochloride to block euphoric effects if the tablet is crushed and then snorted or injected, according to the FDA.
But Targiniq ER still can be abused if swallowed whole, which is currently the most common form of oxycodone abuse, the FDA said.
The drug is approved for patients who do not respond to or cannot tolerate alternative pain treatments and is not intended for as-needed pain relief, the FDA said.
The approval is based on a clinical trial of 601 patients with chronic low back pain and a safety database of more than 3,000 patients, the FDA said. The drug’s most common side effects were nausea and vomiting, the agency reported.
The FDA said it is requiring postmarketing studies of the potential for abuse, increased pain sensitivity, addiction, overdose, and death should Targiniq ER be used for more than 12 weeks.
The drug’s maker, Purdue Pharma, manufactures several other opioids, including transdermal buprenorphine, injectable and oral hydromorphone, morphine sulfate extended-release tablets, and extended-release oxycodone without naloxone.