The FDA announced the approval of Zohydro ER (hydrocodone bitartrate extended-release capsules; Zogenix), the first single-entity, extended-release hydrocodone product.

RELATED: Pain Management Resource Center

Zohydro ER is a Schedule II controlled substance indicated for the management of pain severe enough to require daily, around-the-clock, long-term treatment, and for which alternative treatment options are inadequate.

Zohydro ER includes the updated labeling requirements for all extended-release/long-acting (ER/LA) opioid analgesics that the FDA announced.

The updated warnings more clearly describe the risks and safety concerns associated with ER/LA opioid analgesics, along with their appropriate use. Also, postmarketing studies of Zohydro ER are required to assess the known risks of misuse, abuse, hyperalgesia, addiction, overdose, and death associated with use beyond 12 weeks.

The efficacy of Zohydro ER is based on a clinical study that enrolled over 500 patients with chronic low back pain and showed significant improvement in chronic pain compared to placebo.

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