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Hydrocodone bitartrate extended-release capsules were approved by the Food and Drug Administration Oct. 25 for severe pain requiring daily long-term treatment and for which other treatment options are inadequate.
The drug, to be marketed as Zohydro ER, is the first FDA-approved extended-release formulation of hydrocodone that is not combined with another analgesic. It is classified as Schedule II under the Controlled Substances Act.
In December, an FDA advisory committee recommended against approval of Zohydro, citing the need for a tamper-proof formulation and a stronger risk mitigation strategy to address the high potential for abuse and misuse of the product.
Experts on the Anesthetic and Analgesic Drug Products Advisory Committee voted 11-2, with 1 abstention, against approval, although they agreed that the manufacturer met the standards for approval for the proposed indication.
However, concerns about the potential public health impact of the availability of an extended-release formulation of hydrocodone that does not contain acetaminophen – which would make it more attractive as a drug of abuse, particularly for intravenous drug abusers – or a tamper-resistant design, swayed their votes.
In approving the drug, the FDA noted that it carries new labeling and stronger warnings regarding the risks and safety of extended-release and long-acting opioid analgesics. The new labeling requirements were instituted by the agency in September. The drug also will be included in the Risk Evaluation and Mitigation Strategy (REMS) associated with the new labeling requirements.
"These warnings are expected to improve the safety of all such medicines by encouraging more appropriate prescribing, patient monitoring, and patient counseling practices," the FDA said in a statement. "Zohydro ER is the first opioid to be labeled in this manner."
Approval was based on safety studies of more than 1,100 chronic pain patients as well as efficacy studies of more than 500 chronic low-back-pain patients. Patients taking Zohydro ER in the efficacy study showed significant improvement in chronic pain, compared with those who took placebo.
FDA will require postmarketing studies of Zohydro ER to study potential abuse/overdose and hyperalgesia when used longer than 12 weeks.
Zohydro ER is manufactured by San Diego–based Zogenix.
Elizabeth Mechcatie contributed to this report.
