Monthly update of U.S. Food and Drug Administration (FDA) approvals impacting the workers' compensation industry. myMatrixx's report includes new drug and indication approvals, discontinuation and withdrawals, new dosages or formulations of existing products and newly available generics in the last 12 months.
Monthly Drug News
Most recently marketed by Currax Pharmaceuticals, Zohydro® ER (hydrocodone extended-release capsules) has been removed from sale in the United States. A C-II controlled substance, it was FDA approved in 2013 as the only single-ingredient hydrocodone product for managing severe pain that needs continuous, long-term treatment and that has not responded to prior treatment. In 2015, it was reformulated to incorporate a proprietary technology called BeadTek™ that creates thick, sticky goo if the capsules are opened or crushed and the contents dissolved in liquids or solvents. Its use still was problematic, including lawsuits when some states attempted to ban its use at a state level. Now, the manufacturer has stopped distributing Zohydro® ER and the FDA rescinded approval for it effective in late February. Any patients who have been taking it should be switched to another pain reliever.
Impact to Workers’ Comp
Extended-release hydrocodone continues to be available as Hysingla™ ER and generics. While not the most utilized long-acting opioid, it is still of interest along with other opioids. For any questions about the use of Zohydro®, hydrocodone, or other opioids and potential relatedness to a claim, please consult with your myMatrixx pharmacist.