U.S. Food and Drug Administration staff released voting questions on Teva Pharmaceutical Industries Ltd’s long-acting opioid painkiller for a panel of independent experts who will recommend to the agency whether to approve the drug.
An FDA spokesman on Friday afternoon said the agency staff was still working on the preliminary review of the treatment. The regulator typically issues a review along with the voting questions and other items.
The drug, Vantrela ER, is designed for use every 12 hours for the management of pain severe enough to require around-the-clock treatment in patients who have not derived enough benefit from other treatments.
The abuse of opioids — a class of drugs that includes heroin and prescription painkillers — has assumed epidemic proportions in the United States. The Centers for Disease Control and Prevention (CDC) estimates that 78 Americans die every day from an opioid overdose.
Teva’s drug, which contains the commonly used opioid hydrocodone, is formulated using its proprietary abuse-deterrent technology.
FDA staff members on Friday asked the panel to deliberate on whether the painkiller should be approved for the proposed indication, and if it should carry a label that shows the product is less subject to oral, nasal and intravenous abuse.
The meeting of experts is scheduled for Tuesday. While the FDA is not obligated to follow the advice of the panel, it typically does so.
(Reporting by Natalie Grover in Bengaluru)