In recent developments concerning Zohydro, the new prescription opioid to be marketed by Zogenix, Inc., FDA Commissioner Margaret Hamburg, MD, defended the agency’s decision to approve the medication last October. Dr. Hamburg contended that the drug offers a "unique" option to treat pain despite concerns about potential abuse. Her comments to the Senate Health, Education, Labor and Pensions Committee on March 13 come barely a week after Zogenix said it was making the painkiller available at "select pharmacies".
A key concern over Zohydro has been the lack of an abuse-deterrent formulation. Hamburg told lawmakers "I would love if we had abuse-deterrent formulations that were actually meaningful and effective at deterring abuse in all instances. We are moving in that direction. Right now, unfortunately, the technology is poor." She added that the FDA is working on guidelines to help manufacturers come up with more effective abuse deterrents but gave no timeline for when the guidelines would be finalized.
Read a news report from Reuters here.
Posted on March 17, 2014