US Food and Drug Administration advisors have backed approval of Teva’s abuse-deterrent opioid Vantrela ER.
The Anaesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 14 to 3 to recommend approval of the drug 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.
Teva is pitching the Vantrela ER (hydrocodone bitartrate) as offering some abuse deterrent properties by the oral, nasal, and intravenous routes of abuse; the panel largely agreed voting 14 to 3, 14 to 3 and 16 to 1 in favour of these claims, respectively.
Based on the Committees notes, the firm said it expects the label for the opioid to 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.
Michael Hayden, president of Global R&D and chief scientific officer at Teva, said he is “encouraged” by the decision, noting that “there remains a need for treatment options that help deter potential abuse while still providing people living with pain access to effective relief options.”
According to the American Society of Addiction Medicine, 1.9 million people in the US had a substance use disorder involving prescription pain relievers in 2014, while four in five new heroin users started out misusing prescription painkillers.
The FDA is not bound to follow the recommendations of its advisory panels, but usually does so.
