FDA thumbs up for Teva's abuse-deterrent pain drug

The US Food and Drug Administration has approved Vantrela ER (hydrocodone bitartrate) extended-release tablets [CII] formulated with Teva Pharmaceutical Industries’ (NYSE: TEVA) proprietary abuse deterrence technology.

Vantrela ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product’s approval is supported by a clinical program that evaluated the safety and efficacy of Vantrela ER, as well as its abuse potential in laboratory-based in vitro manipulation and extraction studies, pharmacokinetic studies, and clinical abuse potential (CAP) studies.

“Teva understands the risk of prescription drug abuse is a challenge healthcare professionals face when treating millions of Americans affected by chronic pain,” said Rob Koremans, president and chief executive of global specialty medicines at Teva, adding: “Abuse-deterrent treatments provide options for prescribers that may help deter or mitigate abuse while still preserving access to pain medications for the patients that need them most.”