Extended-Release Hydrocodone Painkiller Approved

FRIDAY, Oct. 25 (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.

More information

To learn more about chronic pain, visit the U.S. National Institute of Neurological Disorders and Stroke.

Related Articles

Learn More About Sharp
Sharp HealthCare is San Diego's health care leader with seven hospitals, two medical groups and a health plan. Learn more about our San Diego hospitals, choose a Sharp-affiliated San Diego doctor or browse our comprehensive medical services.

Health News is provided as a service to Sharp Web site users by HealthDay. Sharp HealthCare nor its employees, agents, or contractors, review, control, or take responsibility for the content of these articles. Please read the Terms of Use for more information.