An experimental, long-acting painkiller made by Teva Pharmaceutical Industries Ltd does not have abuse-resistant properties when taken orally, according to a preliminary review by the U.S. Food and Drug Administration.
The drug, whose proposed trade name is Vantrela ER, did demonstrate resistance to abuse by those seeking to inhale or inject it, the review said.
The review was published on the agency's website on Friday and comes ahead of a June 7 meeting of outside experts who will discuss the drug and recommend whether it should be approved. The FDA is not obliged to follow the advice of its advisory panels but typically does so.
The panel is being asked to decide whether Vantrela ER should be allowed to claim on its label that it deters abuse. The panel will vote separately on whether it likely deters abuse when swallowed, snorted or injected.