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, officials said.
The drug will offer prescribers an additional therapeutic option to treat pain, severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.
"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, 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," the FDA said in a statement. "Zohydro ER is not approved for as-needed pain relief."
Schedule II drugs can only be dispensed via 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 said.
The safety of Zohydro ER -- manufactured by San Diego-based Zogenix Inc. -- was based on clinical studies of more than 1,100 people living with chronic pain. The efficacy of Zohydro ER was based on a clinical study that enrolled more than 500 patients with chronic lower-back pain and showed significant improvement in chronic pain compared to placebo, the FDA said.
The most common side effects of Zohydro ER are constipation, nausea, drowsiness, fatigue, headache, dizziness, dry mouth, vomiting and itching.
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