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FDA Approves Extended-Release, Single-Entity Hydrocodone Product

The U.S. Food and Drug Administration today approved Zohydro ER (hydrocodone bitartrate extended-release capsules) 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, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product.

Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids.

Zohydro ER is in the class of extended-release/long-acting (ER/LA) opioid analgesics. Due to the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with ER/LA opioid formulations, Zohydro ER should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Zohydro ER is not approved for as-needed pain relief.

The approved labeling for Zohydro ER conforms to updated labeling requirements for all ER/LA opioid analgesics announced by the FDA on Sept. 10, 2013.

The new class labeling and stronger warnings will more clearly describe the risks and safety concerns associated with ER/LA opioid analgesics, along with the appropriate use of these medications. These warnings are expected to improve the safety of all such medicines by encouraging more appropriate prescribing, patient monitoring, and patient counseling practices. Zohydro ER is the first opioid to be labeled in this manner.

Schedule II drugs can only be dispensed through a physician's written prescription and no refills are allowed. There are also stringent recordkeeping, reporting, and physical security requirements for Schedule II controlled substances.

The FDA is requiring postmarketing studies of Zohydro ER to assess the known serious risks of misuse, abuse, increased sensitivity to pain (hyperalgesia), addiction, overdose, and death associated with long term use beyond 12 weeks. These studies will also be required for other ER/LA opioid analgesics.

The safety of Zohydro ER is based on clinical studies of more than 1,100 people living with chronic pain. 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.

Zohydro ER will be part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS). Originally approved in 2012, the ER/LA Opioid Analgesics REMS requires companies to make available to health care professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide Medication Guides and patient counseling documents containing information on the safe use, storage, and disposal of ER/ LA opioids.

The most common side effects of Zohydro ER are constipation, nausea, drowsiness (somnolence), fatigue, headache, dizziness, dry mouth, vomiting and itching (pruritus).

Zohydro ER is manufactured by San Diego-based Zogenix, Inc.

SOURCE: FDA, October 25, 2013








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