News


Zohydro ER Refomulation Approved

by Helios | Feb 17, 2015
The Food and Drug Administration (FDA) has approved a new abuse-deterrent formulation of the hydrocodone product Zohydro ER.

The Food and Drug Administration (FDA) has approved a new formulation of the hydrocodone product, Zohydro ER. Zohydro ER, which launched in October 2013, is dosed every 12 hours and was the first single agent formulation of hydrocodone to be available in the United States.

The new formulation contains a technology called BeadTek, which is intended to provide abuse-deterrent properties without altering the extended release properties of hydrocodone when taken orally as prescribed. BeadTek contains pharmaceutical excipients (inactive ingredients) that will form a viscous gel if Zohydro ER is crushed and dissolved in liquids or solvents to prevent misuse and abuse. Transition to Zohydro ER with BeadTek is expected to occur in the second quarter of 2015 for all prescribed strengths ranging from 10 mg to 50 mg, without disruption to patients currently on therapy.1

Notably, the FDA is not allowing the label to include claims of abuse-deterrent properties at this time. The manufacturer, Zogenix, must first provide additional documentation and data to support these claims, consistent with the FDA’s current draft “Guidance for Industry, Abuse-Deterrent Opioids - Evaluation and Labeling” requirements.2

Our Medication Plans and formularies continue to require prior authorization for this medication. As additional information becomes available regarding the new formulation, as well as details of its pending release later in the year, we will keep you informed. Until then, if you have any questions or concerns regarding this Medication Alert, please contact our Clinical Services Team at ask-a-pharmacist@helioscomp.com.

References:

1.    Zogenix Receives FDA Approval of New Formulation of Zohydro ER. http://ir.zogenix.com/phoenix.zhtml?c=220862&p=irol-newsArticle&cat=news&id=2012326

2.    FDA, http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm334743.pdf. 2015.