A joint advisory panel appointed by the Food and Drug Administration (FDA) has given the thumbs-up for the approval of a new prescription opioid, Vantrela ER by Teva Pharmaceuticals. Unlike Zohydro ER—the controversial hydrocodone drug approved by the FDA in 2014—Vantrela ER was specifically designed to deter abuse.
In a press release, Teva announced that the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 14 to 3 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, like Zohydro, is an extended-release formulation of hydrocodone bitartrate. But the new formulation includes abuse-deterrent properties, which were tested under “stressed conditions” that “push the formulation to the limit,” said Dr. Derek Moe, vice president of Drug Delivery Technology at Teva. “Category 1” testing of the abuse-deterrent formulation found that even when the drug was manipulated physically (crushed, chewed, ground, or cut) or chemically (attempting extraction by using a range of temperatures, solvents, or agitations) Vantrela ER’s abuse-deterrent properties held, compared with other drugs.
However, according to a recent FDA preliminary review, the experimental painkiller does not retain these properties when taken orally. One FDA panel member, Dr. Mary Ellen McCann, an associate professor of anesthesia at Harvard Medical School, voted against labeling Vantrela ER as abuse-deterrent by oral consumption. She said, “If one pill doesn’t work, you just take two or just take three, so I think the bar should be higher for oral deterrence.”
The joint advisory committee recommended that the new drug’s labeling, if approved by the FDA, should reflect its abuse-deterrent properties, though a claim that it can “fully prevent abuse” is not possible.
Although the FDA is not bound to follow the guidance of its advisory committees, the agency has a history of following their recommendations, Reuters notes. However, the FDA did fail to follow its advisory panel’s recommendation to keep Zohydro ER off the market due to its high potential for abuse, and even though the panel voted against approval, the FDA approved Zohydro ER in 2014.
In contrast, since the advisory panel’s recommendation of Vantrela ER is positive and the new drug is designed to prevent abuse, FDA approval is almost a certainty.
