The Food and Drug Administration on Wednesday announced the approval of Targiniq ER, an extended-release painkiller designed to combat abuse and counter a national scourge of prescription drug abuse.
Targiniq ER contains a component that blocks the euphoric effects of oxycodone, when it is crushed and snorted or dissolved and injected into the bloodstream.
“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 U.S.,” said Sharon Hertz, deputy director of the Division of Anesthesia, Analgesia and Addiction Products in the FDA’s Center for Drug Evaluation and Research.
While Targiniq ER is expected to deter abuse, the FDA stressed that the drug can still be abused when taken orally – still the most common method for addicts or others looking for a high.
“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 said.
The approval follows a clinical trial of 601 people with chronic low back pain, and is requiring post-market studies to monitor the drug’s use.
Targiniq ER is the second opioid analgesic to be approved as an abuse deterrent
The agency has highlighted its push toward abuse-deterrent drugs, while making clear that painkillers play an importment role in the treatment of a wide array of ailments.
“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,” Hertz said.