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Hysingla ER Alert

December 02, 2014

By:  Dr. Adam Richardson
Director of Physician Services
Claims Eval, Inc.

The U.S. Food and Drug Administration (FDA) approved the original formulation of OxyContin in Dec. 1995.(1) Within three months, Claims Eval noted significant penetration into the workers’ compensation industry.

In April 2010, the FDA approved a reformulated version of OxyContin, which was designed to be more difficult to manipulate for purposes of misuse or abuse. (1) Claims Eval noted no reduction in the volume of Oxycontin prescriptions. But some published literature about a reduction in mortality rate since the change exists.(2)

On October 25, 2013, the FDA approved Zohydro ER, the first extended-release, single-entity hydrocodone-containing drug product.(3) Again within three months, Claims Eval noted penetration into the workers’ compensation industry.

Over this timeframe, the death rate from opioid overdose has also steadily climbed. (4) Therefore, Claims Eval read with trepidation the FDA approval of the extended-release (ER) single-entity opioid analgesic hydrocodone bitartrate (Hysingla ER, Purdue Pharma). It reportedly displays abuse-deterrent properties in line with the FDA’s 2013 draft guidance to industry.

Megan Brooks, writing for Medscape (5) on 11/20/14 notes:

“Hysingla ER has properties that are expected to reduce, but not totally prevent, abuse of the drug when chewed and then taken orally, or crushed and snorted or injected,” the FDA said in a statement. The tablet is difficult to crush, break, or dissolve, it notes, and forms a viscous hydrogel that cannot be easily prepared for injection.

“The FDA has determined that the physical and chemical properties of Hysingla ER are expected to make abuse by these routes difficult,” the agency adds. “However, abuse of Hysingla ER by these routes is still possible.”

“While the science of abuse deterrence is still evolving, the development of opioids that are harder to abuse is helpful in addressing the public health crisis of prescription drug abuse in the US,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the statement.

Claims Eval forecasts that Hysingla ER may be the next drug to hit the market and be over-utilized in worker’s compensation. Claims examiners and insurance carriers would do well to take notice and prospectively track this medication.


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Claims Eval