The manufacturer of the recently approved pure hydrocodone drug Zohydro ER (extended release) announced it will assemble an oversight board designed to spot misuse of the drug.
The outside group will consist of seven medical, addiction and law enforcement specialists, according to Stephen Farr, President and Director of Zogenix.
The panel will look at data from sources including prescribing statistics, law enforcement records and addiction center reports. "We will be monitoring patients, prescribers, pharmacists, supply chains and abusers, so all the populations that would potentially touch our product," Farr told the AP.
Five out of the seven experts on the panel have previously received consulting payments from Zogenix, the article notes.
Zohydro is designed to be released over time, and can be crushed and snorted by people seeking a strong, quick high. It was approved for patients with pain that requires daily, around-the-clock, long-term treatment that cannot be treated with other drugs.
In December 2012, a panel of experts assembled by the Food and Drug Administration (FDA) voted against recommending approval of Zohydro ER. The panel cited concerns over the potential for addiction. In the 11-2 vote against approval, the panel said that while Zogenix had met narrow targets for safety and efficacy, the painkiller could be used by people addicted to other opioids, including oxycodone.
The FDA's decision to approve Zohydro has been criticized by some legislators and public health groups. FDA Commissioner Margaret Hamburg has received letters protesting the decision from 28 state attorneys general and four senators, among others. Law enforcement agencies and addiction experts predict approval of the drug will lead to an increase in overdose deaths.