The US Food and Drug Administration (FDA) has approved extended-release hydrocodone bitartrate (Hysingla ER), an opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Hydrocodone bitartrate ER has properties that are expected to reduce, but not totally prevent, abuse of the drug when chewed and then taken orally, or crushed and snorted or injected. The tablet is difficult to crush, break or dissolve. It also forms a viscous hydrogel and cannot be easily prepared for injection. The FDA has determined that the physical and chemical properties of hydrocodone bitartrate ER are expected to make abuse by these routes difficult. However, abuse of hydrocodone bitartrate ER by these routes is still possible. It is important to note that taking too much hydrocodone bitartrate ER, whether by intentional abuse or by accident, can cause an overdose that may result in 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 United States,” said Janet Woodcock, MD, FDA’s Center for Drug Evaluation and Research, Rockville, Maryland. “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.”
Hydrocodone bitartrate ER is not approved for, and should not be used for, as-needed pain relief. The drug should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management.
As a single-entity opioid, hydrocodone bitartrate ER does not carry the serious liver toxicity risks associated with hydrocodone combination products containing acetaminophen.
The FDA encourages healthcare professionals to review and consider all available information as part of their decision-making when prescribing opioid analgesics.
Hydrocodone bitartrate ER (20, 30, 40, 60, 80, 100 or 120 mg) should be taken every 24 hours. Doses of 80 mg per day and higher should not be prescribed to people who have not previously taken an opioid medication. While the drug contains larger amounts of hydrocodone compared to immediate-release hydrocodone combination products, the range of tablet strengths of hydrocodone bitartrate ER is comparable to existing approved ER opioids.
The safety and effectiveness of hydrocodone bitartrate ER were evaluated in a clinical trial of 905 people with chronic low back pain. Additional data from studies conducted in laboratories and in people demonstrated the abuse-deterrent features of hydrocodone bitartrate ER for certain types of abuse (oral, snorting, and injection).
The most common side effects of hydrocodone bitartrate ER are constipation, nausea, fatigue, upper respiratory tract infection, dizziness, headache, and drowsiness.
The FDA is requiring post-marketing studies of hydrocodone bitartrate ER to assess the effects of the abuse-deterrent features on the risk for abuse of the drug and the consequences of that abuse in the community. In addition, hydrocodone bitartrate ER is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which requires companies to make available to healthcare professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide Medication Guides and patient counselling documents containing information on the safe use, storage, and disposal of ER/LA opioids.