FDA Approves Abuse-Deterrent Opioid, Vantrela ER

The FDA has approved Vantrela ER (hydrocodone bitartrate) extended-release tablets for the management of severe pain requiring daily, around-the-clock, long-term opioid treatment for which alternative treatment options have proven inadequate. The extended-release tablets are formulated to reduce the risk of oral, intranasal, and intravenous abuse via manipulation of the tablets.

The drug was tested in a clinical program evaluating its safety and efficacy, as well as its abuse potential, in laboratory-based and vitro manipulation and extraction studies, pharmacokinetic studies, and clinical abuse potential studies.
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Adverse reactions present in ≥2% of participants in placebo-controlled trials include headache, somnolence, vomiting, dizziness, pruritus, fatigue, diarrhea, insomnia, and anxiety.

—Michael Potts

Reference:

Teva. Teva receives FDA approval for Vantrelatm ER (hydrocodone bitartrate) extended-release tablets [cii] formulated with proprietary abuse deterrence technology [press release].