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Zogenix Touts the "Safe-Use Board" It's Set Up for Painkiller Zohydro

By Associated Press – Mar 26, 2014 at 3:04PM

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The board will keep an eye on stats from patients, prescribers, pharmacists, supply chains, and abusers.

After months of criticism over its recently launched painkiller Zohydro, the maker of the powerful narcotic is highlighting an unusual oversight board that it's assembled to try and prevent abuse of the drug.

Zogenix's president and director, Stephen Farr, told The Associated Press that the outside group of seven medical, addiction and law enforcement specialists will be able to spot early signs of misuse using data from sources that include prescribing statistics, addiction center reports and law enforcement records.

"We will be monitoring patients, prescribers, pharmacists, supply chains and abusers, so all the populations that would potentially touch our product," Farr said in the interview.

The comments come as Zogenix tries to move past negative publicity surrounding Zohydro, the first single-ingredient hydrocodone drug ever approved for U.S. patients. Critics say the pill -- which contains up to five times more hydrocodone than Vicodin -- will add to the epidemic of opioid drug abuse that is blamed for about 16,000 overdose deaths a year.

The Food and Drug Administration approved Zohydro last October and the drug began shipping to pharmacies this month. Now, Zogenix is publicizing its efforts to make sure the drug is used safely. The company's approach is unusual: safety monitoring boards are generally used in experimental drug testing, but rarely for drugs already on the market.

While they acknowledge that Zogenix's approach is innovative, experts say there is little evidence that the so-called "safe-use board" will ensure Zohydro is used appropriately.

"Is it nice that they're putting together an external review panel of independent people? That's fine," said Dr. Allen Vaida of the Institute for Safe Medication Practices. "But is the group going to have any authority or power whatsoever?"

Critics also question whether the panel will be truly independent from the company. Five out of seven experts on the board have previously received consulting payments from the company. All panel members will be compensated for quarterly meetings to review Zohydro data. And at least two of the physicians on the panel have served as consultants and paid speakers for other drug companies, including Pfizer and Eli Lilly & Co.

"If Zogenix is paying them, they're working for Zogenix," said Dr. Andrew Kolodny, co-founder of Physicians for Responsible Opioid Prescribing. "It's plain silly to pretend this group is external and independent."

Zogenix, which is based in San Diego, said that none of the members have ever served as paid speakers for the company and that they are "barred from any other paid role with Zogenix in the future."

And to address concerns that the group will not have power, Zogenix's Farr said the group "will have the ability to go directly to our board of directors" if its recommendations on Zohydro are not heeded.

The move comes amid ongoing criticism of Zohydro from anti-addiction groups, politicians and law enforcement officials who say the drug will be easily abused by people addicted to opioids. Zohydro is an extended-release version of the opioid hydrocodone, which is designed to provide 12 hours of relief for patients with round-the-clock chronic pain.

Before Zohydro's approval hydrocodone was only available in immediate-release combination pills like Vicodin. Much of the concern over Zohydro's safety has focused on its high dose of hydrocodone, but the formulation is not unusual compared to other extended-release opioids.

Nearly a dozen members of Congress and more than two dozen state attorneys general have called on the FDA to withdraw Zohydro or to require that it be reformulated to prevent users from crushing the pills for snorting or injection.

The FDA has repeatedly stated that Zohydro meets its standards and provides an important treatment option for patients with chronic pain. The agency also points out that abuse-deterrent formulations are in the early stages of development. The FDA has only approved one anti-abuse opioid: a crush-resistant version of OxyContin approved in 2010.

Under current FDA requirements, Zogenix and all other makers of extended-release opioid drugs must sponsor training for doctors and distribute informational pamphlets to patients. Zogenix's monitoring board is a voluntary measure on top of those FDA requirements.

In the interview last week, Zogenix's president stressed that the board is only one safety measure it's using. The company is also educating doctors and compensating sales representatives based on educational goals, rather than drug sales targets.

But even experts who work with Zogenix and other pain drugmakers say such multi-pronged safety plans -- known as risk evaluation and mitigation strategies, or REMS -- have not curbed the rising number of fatal overdoses.

"There is no evidence whatsoever that any of the REMS interventions have been effective," said Dr. Nathaniel Katz, a former FDA advisor who now consults for drugmakers. "How would you consider them effective in the context of all those deaths?"

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