FDA Approves Vantrela ER

Released: 01/20/2017   By: Heidi Dufrene, PharmD

Vantrela ER (Hydrocodone Bitartrate) from Teva Pharmaceuticals has recently been granted approval from the FDA. Vantrela ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. Vantrela ER tablets are considered abuse-deterrent, if manipulated by oral, nasal or intravenous route. Teva’s proprietary abuse-deterrent technology is composed of three complementary formulated layers, designed to release medications over twelve hours. The tablet would maintain its ER properties even when manipulated into a fine powder. Vantrela ER will be available in 15, 30, 45, 60 and 90mg tablets, meant to be taken twice daily.

According to the FDA, current abuse-deterrent technology does not prevent all methods of abuse and there is no sufficient evidence that opioids with abuse-deterrent labeling reduces abuse. Current Official Disability Guidelines (ODG) state that extended-release opioids are not recommended as first-line therapy of acute or chronic non-malignant pain. Currently, all long-acting, abuse-deterrent opioids are considered an “N” drug on the ODG formulary, which means they are not preferred by the ODG organization to initially treat patients.