FDA advisory panels back Teva's Vantrela ER

The US Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee yesterday voted 14 to three to recommend approval of 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, from Israel’s Teva Pharmaceutical Industries (NYSE: TEVA) is an extended-release formulation of hydrocodone bitartrate with Teva’s proprietary abuse deterrence technology.

The positive vote comes despite FDA staff briefing documents which warned that Vantrela ER does not have abuse-resistant properties when taken orally. However, it did demonstrate resistance to abuse by those seeking to inhale or inject it, the documents said.