FDA Approves ER Hydrocodone With Abuse Deterrence Technology
The FDA has approved Vantrela ER (hydrocodone bitartrate, Teva) extended-release tablets [CII] with Teva’s proprietary abuse deterrence technology targeting oral, intranasal and IV routes. Vantrela ER is indicated to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

A clinical program substantiated the product’s approval through evaluations of the safety and efficacy of Vantrela ER and its abuse potential in laboratory-based in vitro manipulation and extraction studies, pharmacokinetic studies, and clinical abuse potential studies....