FDA approves opioid with abuse-deterrent properties

The FDA has approved an extended release hydrocodone bitartrate, an opioid analgesic to treat severe chronic pain.

Hydrocodone bitartrate (Hysingla ER, Purdue Pharma) has some properties that may deter abuse because it is difficult to break, crush or dissolve and becomes a viscous gel that is difficult to inject when dissolved. Abuse and overdose, however, still are possible. It is intended only for pain that requires daily, 24-hour, long-term treatment and is not intended to be taken as needed.

Unlike many other opioid tablets, the extended-release form of hydrocodone bitartrate does not contain acetaminophen, which is associated with liver toxicity.

“While the science of abuse deterrence is still evolving, the development of opioids that are harder to abuse is helpful in addressing the public health crisis of prescription drug abuse in the US,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release.

“Preventing prescription opioid abuse is a top public health priority for the FDA, and 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 agency to balance addressing this problem with ensuring that patients have access to appropriate treatments for pain.”