FDA Advisory Committee Recommends Teva’s Abuse-Deterrent Opioid
The Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration (FDA) has recommend for approval Teva Pharmaceutical Industries’ Vantrela ER 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. Vantrela ER is an extended-release formulation of hydrocodone bitartrate with Teva's proprietary abuse deterrence technology.
Based on the committees' votes, Teva anticipates, if approved, the label for Vantrela ER will describe the product's abuse-deterrent properties that are expected to reduce, but not totally prevent, abuse of the drug when the tablets are manipulated. The FDA is not bound by the recommendations of its advisory committees, but will consider their guidance during the review of the new drug application for Vantrela ER.
Source: Teva Pharmaceutical Industries