FDA panels recommend Teva's Vantrela ER

FDA's Anesthetic and Analgesic Drug Products committee and Drug Safety and Risk Management advisory committee voted 14-3 to recommend approval of Vantrela ER hydrocodone bitartrate ( CEP-33237) from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) to treat pain severe enough to require around-the-clock, long-term opioid treatment. The committees voted 14-3 to support labeling Vantrela as abuse deterrent by the oral route, 14-3 by the nasal route and 16-1 by the IV route.

Though the committees said Teva's product showed an incremental improvement in abuse deterrent properties and effectively reduced pain, panel members expressed concern over FDA's standards for abuse deterrent labeling of opioid products. Panel members called for studies that report functional endpoints in addition to patient-reported pain scores, as well as longer trials to evaluate chronic opioid use. ...