FDA Approves Hydrocodone Product With Abuse-Deterrent Properties

The FDA today approved hydrocodone bitartrate, an extended-release opioid analgesic for treating severe pain that requires daily long-term opioid treatment and for which other treatment options are inadequate.

The FDA today approved Purdue Pharma's hydrocodone bitartrate (Hysingla ER), an extended-release opioid analgesic for treating severe pain that requires daily long-term opioid treatment and for which other treatment options are inadequate.

Hysingla ER is expected to reduce, but not totally prevent, abuse of the drug when chewed and taken orally, crushed and snorted, or injected. Due to its thick gel, injection of the drug is deterred. In addition, the tablet is hard to crush, break, or dissolve.

“The burden of chronic pain and the abuse of prescription medications are both pressing societal problems,” said Charles E. Argoff, MD, Professor of Neurology at Albany Medical College and Director of the Comprehensive Pain Center at Albany Medical Center in New York, in a press release from Purdue Pharma. “Opioids are an essential tool in our arsenal of medical treatments options, so greater availability and use of opioid analgesics with abuse-deterrent properties has the potential to help alleviate suffering among people with chronic pain while reducing the abuse of these medications. Furthermore, this product gives treatment providers the option to use hydrocodone without acetaminophen if they are concerned that their patients may be taking too much acetaminophen on a daily basis.”

Despite efforts to decrease the chances of abuse, it is still possible, according to the FDA, which warned that taking too much Hysingla can result in an overdose or death.

“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 U.S.,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, 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 1 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.”

The FDA is requiring postmarketing studies of Hysingla ER to assess the effects of the drug's abuse-deterrent features on the risk for its abuse, as well as the consequences of that abuse in the community.

The FDA also directed that Hysingla ER is not intended for patients seeking as-needed pain relief. Instead, it should be used only in situations where alternative treatment options are ineffective, inadequate at treating the pain, or not tolerated.

Hysingla ER does not carry serious liver toxicity risks associated with hydrocodone combination products containing acetaminophen.