Teva announced that the Food and Drug Administration (FDA) has approved Vantrela ER (hydrocodone bitartrate) extended-release tablets 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.

In June 2016, the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA had recommended the approval of Vantrela ER. The FDA approval was supported by data from 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. 

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Vantrela ER is formulated with the Company’s proprietary abuse deterrence technology. The product labeling describes abuse-deterrent properties that are expected to reduce but not totally prevent, oral, intranasal, and intravenous abuse of the drug when the tablets are manipulated. 

Hydrocodone is a full opioid agonist with a principal therapeutic action of analgesia. It has relative selectivity for the mu-opioid receptor although it can interact with other opioid receptors at higher doses. Specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of hydrocodone.

Vantrela ER, a CII controlled substance, will be available as 15mg, 30mg, 45mg, 60mg, and 90mg strength extended-release tablets in 100-count bottles.

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