The U.S. Food and Drug Administration (FDA) today approved hydrocodone bitartrate (Hysingla ER), an extended-release 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. The product has approved labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance for industry, Abuse-Deterrent Opioids – Evaluation and Labeling.
Abuse-Deterrence Properties
The new product 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 the new product are expected to make abuse by these routes difficult. However, abuse of the drug by these routes is still possible, and overdosing 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, 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.”
About Hydrocodone Bitartrate
Extended-release hydrocodone bitartrate is not approved for, and should not be used for, as-needed pain relief. Given the drug’s risks for abuse, misuse, and addiction, it 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, The new drug does not carry the serious liver toxicity risks associated with hydrocodone combination products containing acetaminophen. The FDA encourages health-care professionals to review and consider all available information as part of their decision-making when prescribing opioid analgesics.
Strengths of the new product contain 20, 30, 40, 60, 80, 100 and 120 mg of hydrocodone to be taken every 24 hours. Doses of 80 mg/d and higher should not be prescribed to people who have not previously taken an opioid medication. While the product contains larger amounts of hydrocodone compared to immediate-release hydrocodone combination products, the range of tablet strengths of the drug is comparable to existing approved extended-release opioids.
The safety and effectiveness of the product 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 the drug for certain types of abuse (oral, snorting, and injection). The most common side effects are constipation, nausea, fatigue, upper respiratory tract infection, dizziness, headache, and drowsiness.
The FDA is requiring postmarketing studies to assess the effects of the abuse-deterrent features on the risk for abuse and the consequences of that abuse in the community. In addition, the new drug is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS), which requires companies to make available to health-care professionals educational programs on how to safely prescribe extended-release/long-acting opioid analgesics. ■
