ICBioethics Blog 

Discussion on Zohydro

Written by: Leah Jeunnette, Ph.D.(c)

Pain medication is a controversial topic in medicine because of potential addiction and dependency. The FDA reviews many new investigational drug protocols every year, and throughout the various stages, many different components are taken into consideration. For pain medications, there are discussions regarding the benefits of the new pain meds versus the risk of addiction or dependency.

Zohydro® is currently being discussed for that very reason. Although the FDA has approved Zohydro, many are calling for its approval to be revoked. Those who are against the approval argue that not only is potential addiction problematic, but also serious is the concern of overdoses. Those who support this approval focus on individuals with chronic pain and their need for effective medication.

Interestingly, the FDA sought to address a separate issue just one day before the approval announcement. Hydrocodone drugs were reclassified as Schedule II drugs instead of the previous Schedule III. This means there is more regulation now for all hydrocodone drugs, including Zohydro. While the FDA maintains that these decisions were made separately, one cannot help but speculate about an overlap of these two decisions. For now, the drug is scheduled to be released in March with warnings regarding abuse and addiction.

Interesting to note: Currently there is no abuse-deterrent formulation of Zohydro available. Zogenix, the maker of Zohydro, is creating one, but that is still years away from release.

Mitch GennusoComment