FRIDAY, Oct. 25, 2013 (HealthDay News) -- Zohydro ER (hydrocodone bitartrate extended-release) has been approved by the U.S. Food and Drug Administration for severe pain that requires round-the-clock long-term treatment, the agency said Friday in a news release.
Citing the potential for opioid abuse or dependency, even if the product is used as prescribed, the agency said the drug should be used only in cases when other painkillers have proven ineffective. The schedule II controlled substance should only be used to treat daily, chronic pain, not for as-needed pain relief, the FDA said.
The agency said it has ordered post-marketing studies of Zohydro ER to evaluate use beyond 12 weeks, and its overall potential for abuse.
The drug was evaluated in clinical studies involving more than 1,100 people with chronic pain. The most common side effects included constipation, nausea, drowsiness, headache, dizziness, dry mouth and itching.
Zohydro ER is produced by Zogenix, based in San Diego.
To learn more about chronic pain, visit the U.S. National Institute of Neurological Disorders and Stroke.