FDA Approves First Extended-Release, Single-Entity Hydrocodone Product

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The U.S. Food and Drug Administration (FDA) today approved hydrocodone bitartrate extended-release capsules (Zohydro ER) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.

The drug, 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.

The new product is in the class of extended-release/long-acting 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 extended-release/long-acting opioid formulations, hydrocodone bitartrate 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. Hydrocodone bitartrate is not approved for as-needed pain relief.

The most common side effects of hydrocodone bitartrate are constipation, nausea, drowsiness, fatigue, headache, dizziness, dry mouth, vomiting, and pruritus.

New Safety Measures

The approved labeling for hydrocodone bitartrate conforms to updated labeling requirements for all extended-release/long-acting opioid analgesics announced by the FDA on September 10, 2013.

The new class labeling and stronger warnings will more clearly describe the risks and safety concerns associated with extended-release/long-acting 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. Hydrocodone bitartrate is the first opioid to be labeled in this manner.

The FDA is requiring postmarketing studies of hydrocodone bitartrate to assess the known serious risks of misuse, abuse, hyperalgesia, addiction, overdose, and death associated with long term use beyond 12 weeks. These studies will also be required for other extended-release/long-acting opioid analgesics.

The safety of hydrocodone bitartrate is based on clinical studies of more than 1,100 people living with chronic pain, and the efficacy 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. ■