FDA approves new Zohydro ER with abuse-deterrent propertiesReprints
The U.S. Food and Drug Administration has approved a new version of opioid Zohydro ER that contains abuse-deterrent properties, according to Zogenix Inc., the pharmaceutical firm that manufactures the powerful pain medication.
Zohydro ER was first approved by the FDA in 2013 and released to the market in March 2014. It is classified as a Schedule II controlled substance, meaning it requires a doctor's prescription and refills are not allowed.
The new formulation of the pill is designed to provide abuse-deterrent properties “that immediately form a viscous gel when crushed and dissolved in liquids or solvents,” San Diego-based Zogenix said Friday in a statement.
Transition to the new formulation is expected to occur during the second quarter of 2015 and won't disrupt patients who are in the midst of treatment, according to the statement.
Despite its approval, the FDA hasn't issued the drug an “abuse deterrent” product label. But Zogenix said in its statement that it will submit study findings to the FDA later this year in an effort to secure the label.
While other opioids used in workers comp, such as Vicodin, mix hydrocodone with non-narcotic pain relievers such as acetaminophen and ibuprofen, Zohydro ER is an extended-release pure hydrocodone pill.
The drug was listed by several survey respondents as a new or emerging workers comp issue to note, according to CompPharma L.L.C.'s most recent “Prescription Drug Management in Workers Compensation” poll.
And in March 2014, Massachusetts Gov. Deval Patrick sought to ban the drug's availability in the state until Zogenix produced a crush-resistant form.