FDA Approves Zohydro ER with Abuse-Deterrent Properties

Food and Drug Administration (FDA) has approved a new formulation of Zohydro^® ER with abuse-deterrent properties. The new formulation uses a technology that allows the drug to maintain its release properties when used as intended, according to a press release from Zogenix. The abuse-deterrent system, known as BeadTek, incorporates “pharmaceutical excipients” that create a viscous gel when the medication is crushed and dissolved in a liquid or solvent, thus making the product more difficult to abuse through methods that involve crushing, breaking, or dissolving the drug. In February 2014, Zohydro ER became the first extended-release, single-ingredient hydrocodone product to receive approval for use in the United States. Approval of the drug came under criticism, with some organizations arguing that the potential for addiction, abuse, and misuse could outweigh therapeutic benefits, in part because the drug lacked abuse-deterrent properties. Zogenix indicates that transition to the new abuse-deterrent formulation will take place in second quarter 2015.