FDA Approves Abuse-Resistant Extended-Release Hydrocodone

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FDA Approves Abuse-Resistant Extended-Release Hydrocodone
FDA Approves Abuse-Resistant Extended-Release Hydrocodone

THURSDAY, Nov. 20, 2014 (HealthDay News) -- The U.S. Food and Drug Administration has approved Hysingla ER (hydrocodone bitartrate), an abuse-resistant, extended-release form of hydrocodone.

In a Thursday news release, the agency said the drug 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. Hysingla ER shouldn't be used for "as-needed" pain relief, the agency added.

The drug's safety and effectiveness were evaluated in clinical studies involving 905 people with chronic low-back pain. The most common side effects were: constipation, nausea, fatigue, upper respiratory tract infection, dizziness, and headache.

"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," Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, said in an FDA news release.

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.

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