FDA advisory committees recommend approval of Teva abuse-deterrent opioid

Two FDA committees voted 14-3 to recommend approval of Vantrela ER, according to a press release issued by Teva Pharmaceuticals.

The drug was designed for "management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate," according to the release.

Vantrela ER is a formulation of hydrocodone bitartrate that has both extended-release and abuse-deterrent technologies, Teva stated.

According to the release, the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee also voted in favor of labeling Vantrela ER as an abuse-deterrent product by oral, nasal and IV routes of abuse 14-3, 14-3 and 16-1, respectively.

“There remains a need for treatment options that help deter potential abuse while still providing people living with pain access to effective relief options,” Michael Hayden, MD, PhD, president of global research and development and chief scientific officer at Teva, said in the release. “We are encouraged by the outcome of today’s FDA Advisory Committee meeting and support for labeling as an abuse-deterrent product by the oral, nasal and IV routes of abuse. We believe in the potential of both Vantrela ER and our proprietary abuse deterrence technology.”

The FDA is not bound by these recommendations, the release stated, but will take them into consideration for the New Drug Application review of Vantrela ER.