Powerful painkiller Zohydro criticized by Pennsylvania AG

A new drug touted as 10 times more potent than the prescription painkillers now available will be on the market in March and could be deadlier than the heroin and opiates responsible for dozens of overdose deaths this year, according to the state attorney general and other critics.

The Food and Drug Administration approved Zohydro ER last year despite an advisory panel's recommendation that it be rejected because of concerns about the potential for addiction.

“I'm really worried about it,” Gary Tennis, state Secretary of Drug and Alcohol Programs, said last week. “They say they're going to make it tamper-resistant. We'll see.”

“Once abuse starts, look out,” said Tim Phillips, director of Community Prevention Services at Westmoreland Community Action. “What are they doing? I think pharmaceutical companies are pressing their own agenda.”

Kathleen Kane is one of 28 attorneys general who wrote the FDA in December, asking the agency to reconsider its decision.

“We believe your approval of Zohydro ER has the potential to exacerbate our nation's prescription drug abuse epidemic because this drug will be the first hydrocodone-only opioid narcotic that is reportedly five to 10 times more potent than traditional hydrocodone products, and it has no abuse-deterrent properties,” the attorneys general wrote.

“We hope that the FDA either reconsiders its approval of Zohydro ER, or sets a rigorous time line for Zohydro ER to be reformulated to be abuse-deterrent while working with other federal agencies on how (it) can be marketed and prescribed.”

Zohydro ER contains a higher dosage of pure hydrocodone than Vicodin. Unlike Vicodin, the drug does not contain aspirin or acetaminophen. Acetaminophen was removed because of liver-damage concerns.

In a statement, Zogenix Inc. of San Diego, the drug's maker, said the company agreed to “voluntary initiatives that go above and beyond FDA requirements,” including education resources for patients, pharmacists and physicians, and experts who will monitor sales for diversion and abuse.

The company is working to develop an abuse deterrent formulation.

“We are currently evaluating two different technologies to ensure we develop the most effective formulation to minimize misuse and abuse,” read the statement.

Dr. J. Douglas Bricker, dean of the Mylan School of Pharmacy at Duquesne University, said the marketing of Zohydro is reminiscent of the release of OxyContin on the marketplace. The drug was aggressively marketed as a “miracle pain reliever,” but once it was diverted for street sales and addiction grew, its luster as a solution to chronic pain diminished.

“This pattern will go away and there will be another drug to replace it,” Bricker said of Zohydro.

In 2012, an FDA advisory panel voted 11-2 to reject the drug's approval, but the agency said the benefits outweigh the risks and overruled the panel.

Bricker, who teaches the course Drugs of Abuse at Duquesne, said drug companies are searching for medications that will help the significant number of people who suffer from chronic pain. Zohydro provides around-the-clock pain relief, according to the company's website.

“Chronic pain is the most difficult to zero in on for a cause and to manage. You want to get it to the right people and not to the wrong people,” Bricker said. “It's very complicated.”

Most painkillers contain an ingredient such as Narcan to prevent the user from abusing it by crushing and injecting it or snorting the powder, Bricker said. But Zohydro comes in capsule form, which can be crushed or snorted and taken with alcohol to increase the euphoric effects, in turn increasing the risk of addiction.

“It makes you feel good because it works on certain receptors in the brain,” Bricker said. “Over time, you require more drugs.”

Richard Gazarik is a staff writer for Trib Total Media. He can be reachedat 724-830-6292 orrgazarik@tribweb.com.