FDA Approves Extended-Release Hydrocodone
Zohydro ER, a Schedule II controlled substance under the Controlled Substances Act, is the first FDA-approved product containing the opioid analgesic hydrocodone not combined with another nonopioid analgesic such as acetaminophen, as well the first extended-release (ER) hydrocodone product.
Zohydro ER is in the class of ER/long-acting (LA) opioid analgesics, which carry with them the risk for addiction, abuse and misuse, even at recommended doses. The FDA recently revised mandatory labeling for these agents. Labels now must state that these drugs should be reserved for use in patients for whom alternative treatment options are ineffective, not tolerated, or otherwise would be inadequate to provide sufficient management of pain. Zohydro ER is not approved for as-needed pain relief.
The approved labeling for Zohydro ER makes it the first drug in its class to conform to the updated labeling requirements for all ER/LA opioid analgesics, which were announced by the FDA on Sept. 10, 2013.The new class labeling and stronger warnings more clearly describe the risks and safety concerns associated with ER/LA opioid analgesics, along with the appropriate use of these medications.
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 associated with long-term opioid use. These studies also will be required for other ER/LA opioid analgesics.
The safety of Zohydro ER is based on clinical studies of more than 1,100 individuals living with chronic pain. The efficacy of Zohydro ER is based on a clinical study that enrolled more than 500 patients with chronic low back pain who showed significant improvement with Zohydro ER compared with placebo.
Zohydro ER will be part of the ER/LA opioid analgesics Risk Evaluation and Mitigation Strategy (REMS). Originally approved in 2012, the REMS for ER/LA opioid analgesics requires companies to make educational programs on how to safely prescribe ER/LA opioid analgesics available to health care professionals and to provide medication guides and patient counseling documents containing information on the safe use, storage and disposal of these agents.
The most common side effects of Zohydro ER are constipation, nausea, drowsiness (somnolence), fatigue, headache, dizziness, dry mouth, vomiting and itching (pruritus).
For more information, including full prescribing information, go to www.zogenix.com
Based on a press release from the FDA.