The U.S. Food and Drug Administration approved an extended-release (ER) opioid analgesic that has abuse-deterrent properties.
The drug, dubbed Hysingla ER, has properties that are expected to reduce abuse if chewed and then taken orally, or even snorted or injected, the FDA reported. The tablet is also extremely difficult to crush or dissolve, and also forms a thick gel that is tricky to prepare for injection. The drug will be prescribed to patients who need around the clock long-term opioid treatment.
Despite these precautions, abuse of Hysingla ER is still possible and overdose resulting in death can occur.
"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, 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."
The safety of the drug was evaluated in a clinical trial of 905 people with chronic low back pain; lab tests also helped demonstrate the anti-abuse qualities of the drug.
The drug has not been approved for as-needed pain relief, and should only be prescribed to people who have not seen success in alternative treatment methods. Strengths of Hysingla ER contain 20, 30, 40, 60, 80, 100 and 120 milligrams (mg) of hydrocodone to be taken every 24 hours. The FDA warns doses of 80 mg or higher should not be prescribed to those who have not taken an opioid before.
