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March 01. 2014 10:53PM

Release of powerful painkiller Zohydro has officials worried

Law enforcement and medical experts are worried about the imminent release of a powerful new painkiller they say will only exacerbate the state's twin epidemics of prescription drug and heroin abuse.
 
 
The new drug, Zohydro ER, is a time-release form of hydrocodone that will be available in doses as high as 50 mg. An advisory committee of the federal Food and Drug Administration voted, 11-2, last March not to approve the drug, citing its potential for abuse and overdose.
 
 
But last fall, the FDA approved the drug anyway, and it is expected to hit the market next month.

In December, New Hampshire Attorney General Joseph Foster joined with his counterparts in 28 other states in signing a letter urging the FDA to reconsider its approval of Zohydro ER.

Prescription opiates continue to pose big problems in New Hampshire, Foster told the New Hampshire Sunday News, including a spike in heroin addiction and overdoses.

Addicts often switch to heroin when they can no longer obtain painkillers legally, since heroin is cheaper than the prescription drugs illegally sold on the street.

"We have a heroin epidemic, and the heroin epidemic is linked to these lawful drugs," Foster said. "At a time when we're trying to fight these fights, the approval of this drug seems to be running counter to some of those efforts."

Dr. Gilbert Fanciullo is director of pain medicine at Dartmouth-Hitchcock Medical Center. He was co-chairman of a national committee, appointed by the American Pain Society and American Society of Pain Medicine, that created guidelines for use of opioids in the United States.

Fanciullo said: "I know a lot about opioids, and I know a lot about the danger of addiction from the use of these drugs.

"I can see no medical advantage for allowing this drug on the market. And I can see enormous opportunities for injury to my patients and my neighbors.

"People who are addicted to these drugs will obtain these drugs, crush them up and snort them," he said. "So there's a very high risk, as far as I'm concerned, of abuse and addiction and diversion."

Fanciullo said he had followed the FDA advisory panel's 11-2 vote against approving the drug last year., so he was stunned when the agency later approved it.

He said his primary concern is that, unlike some prescription painkillers, Zohydro ER will not come in a tamper-resistant form, which prevents addicts from crushing the tablets and snorting the drug to get the maximum dose all at once.

"Hydrocodone for at least the last decade has been one of the two most abused drugs in the United States," along with Oxycontin, Fanciullo said.

"This is a drug that's one of the most abused drugs in the country, and all of a sudden, it's going to be available in a non-tamper-resistant form at high doses," he said. "Who's in charge?"

An FDA spokesman told the Sunday News last week the agency is "extremely concerned about the inappropriate use of opioids." However, FDA press officer Morgan Liscinsky said the agency had determined "after careful consideration" that Zohydro ER "meets our regulatory requirements" and that "the product's benefits outweigh its risks when used as intended."

The drug was not approved for "as-needed pain relief," Liscinsky said in an email, but should be reserved for "severe pain requiring daily, around the clock, long-term treatment and for which alternative treatment options are inadequate."

In a statement, Zogenix, which manufactures the drug, said the availability of an acetaminophen-free formulation of extended-release hydrocodone is "an important therapeutic option for chronic pain patients."

The company noted acetaminophen overdose is a leading cause of liver failure in the United States, and 63 percent of it can be attributed to the use of hydrocodone that contains that drug.

Sgt. Brian LeVeille, head of the Special Investigations Unit at the Manchester Police Department, said he's already received notice from the Drug Enforcement Administration that Zohydro ER is coming. One concern, LeVeille said, is that the new drug will come in higher doses than other prescription opiates on the market. And the lack of an abuse-deterrent formulation means it can be crushed and snorted, he said. "We've got a big enough problem with the oxycodone ... and now we're going to introduce something new out there that they can get their hands on?'' he said.

"I can tell you definitively, without a doubt, we don't even have any Zohydro addicts yet,'' LeVeille said, "but we will have them. And when we have them, they will not stay Zohydro addicts. They will shift to heroin."A single oxycodone pill costs $30 on the street; $100 buys a gram of heroin, which can provide five to 10 doses, depending on the level of addiction and tolerance, LeVeille said.

"That's why the heroin problem is so out of control right now," LeVeille said.

In their Dec. 10 letter, the attorneys general asked the FDA to either reconsider its approval of Zohydro ER or set a "rigorous" timeline for the drug to be reformulated to be abuse-deterrent. They also asked the FDA to work with other federal agencies to impose restrictions on how the drug can be marketed and prescribed.

In response, Sally Howard, the FDA's deputy commissioner for policy, planning and legislation, told the attorneys general that Zohydro ER was approved as a Schedule II controlled substance, which means it can only be dispensed with a written prescription (it can't be called in to a pharmacy) and no refills are allowed.

Howard noted there currently are no hydrocodone products with "meaningful" abuse-deterrent properties, but said the FDA will "do what we can" to support Zogenix in developing such a formula for Zohydro ER.

Meanwhile, questions are mounting about how the drug was approved.

Last week, U.S. Sens. Joe Manchin, D-W.Va., and David Vitter, R-La., sent a letter to the University of Rochester's medical school dean, raising concerns about what they called "pay-to-play" meetings hosted there between drug manufacturers and the FDA officials who regulate them.

The senators asked university officials to provide by March 30 detailed accounts of meetings at which drug company officials reportedly paid "upwards of" $35,000 to attend meetings with FDA officials. The senators also questioned the possible role those meetings played in the Zohydro approval process.

Asked about such allegations of improper influence, the FDA's Liscinsky said agency officials "currently are unaware of any improprieties" involving the groups that sponsored those meetings. "However, we are looking closely at these organizations and the FDA's involvement with them," she said.

swickham@unionleader.com


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