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FDA approves new hydrocodone product that's hard to abuse

January 08, 2015

By Kelly Soderlund

The U.S. Food and Drug Administration has approved an extended-release hydrocodone product with properties that can reduce abuse of the drug.

Hysingla ER (hydrocodone bitartrate) is an opioid analgesic that can treat pain severe enough to require daily, around-the-clock-long-term use. The tablet is difficult to crush, break or dissolve and it also forms a thick gel and cannot be easily prepared for injection. Because of those characteristics, the FDA has determined it would be difficult to abuse the drug.

"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, M.D., director of the FDA's Center for Drug Evaluation and Research. "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."

Hysingla ER comes in strengths of 20, 30, 40, 60, 80, 100 and 120 milligrams of hydrocodone to be taken every 24 hours. The safety and effectiveness of Hysingla ER were evaluated in a clinical trial of 905 people with chronic low back pain.

The FDA is requiring postmarketing studies of Hysingla ER to assess the effects of the abuse-deterrent features on the risk and consequences for abuse of the drug. Dr. Paul Moore, professor of pharmacology, dental anesthesiology and dental public health at the University of Pittsburgh School of Dental Medicine, said the availability of this drug likely won't affect many dentists.
"Hysingla ER is a delayed release single-entity formulation that contains only hydrocodone.  It is indicated specifically for severe, poorly controlled chronic pain and will have few indications in dental medicine and in the management of acute postoperative pain," said Dr. Moore, also a member of the ADA Council on Scientific Affairs. "However, as these formulations become available, it will be important for dentist to know if a patient is taking an opioid such as Hysingla because of possible drug interactions with prescribing analgesics and sedatives."