HealthDay News — The United States Food and Drug Administration (FDA) has approved hydrocodone bitartrate (Hysingla ER), an abuse-resistant, extended-release form of hydrocodone.
“Preventing prescription opioid abuse is a top public health priority for the FDA,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research in an agency press release.
“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 is sanctioned for long-term severe pain that requires daily, around-the-clock treatment. The tablet is difficult to crush, break, or dissolve, making it resistant to abuse. But the medication can still be abused, and an overdose can lead to death, the FDA warned. The drug shouldn’t be used for “as-needed” pain relief, added the agency.
The drug’s safety and effectiveness were evaluated in clinical studies involving 905 people with chronic low-back pain. The most common side effects included constipation, nausea, fatigue, upper respiratory tract infection, dizziness, and headache.
The FDA said it has ordered a post-marketing study to further assess the drug’s potential for abuse. Hysingla ER is produced by Stamford, Conn.-based Purdue Pharma.