Experts say new painkiller Zohydro ER could produce more addicts on LI

Dr. Thomas Jan, a Massapequa pain doctor who

Dr. Thomas Jan, a Massapequa pain doctor who sits on the country's heroin task force, believes a new drug called Zohydro could lead to a spike in the number of both pain pill addicts and overdose deaths on Long Island. (March 21, 2013) (Credit: Newsday / Alejandra Villa)

Law enforcement agencies and Long Island drug addiction experts fear a powerful new painkiller that may be nearing federal approval could create more addicts and cause overdose deaths to spike.

The purer, more potent version of hydrocodone medication is called Zohydro ER. Hydrocodone is the region's -- and the nation's -- second most-abused medicine, according to experts. The new drug is potentially 10 times stronger than any version of the medication currently available, according to public officials and drug treatment experts in Nassau and Suffolk counties.

New York City special narcotics prosecutor Bridget Brennan, who has prosecuted major cases against Long Island pain doctors, said Zohydro, if approved, would probably become a favorite choice among local opioid abusers.


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"The approval of a new and more powerful addictive pain reliever is a step in the wrong direction," Brennan said. "With addiction and overdose death rates soaring, the FDA should focus on restricting, not expanding, the availability of narcotic drugs."

If approved, Zohydro would be the first pure hydrocodone medication available in the United States and would be prescribed to patients in moderate or severe chronic pain. Current forms of the medication, such as Vicodin, are combined with weaker painkillers like acetaminophen.

In 2012, hydrocodone played a role in at least 20 overdose deaths in Suffolk and at least seven in Nassau, according to county medical examiner records. That's an increase from 2011 when the drug played a role in at least 17 deaths in Suffolk and at least four in Nassau, records show.

Law enforcement agencies said Long Island's epidemic of painkiller abuse has been curbed somewhat in the past year due to more pharmacist education, the establishment of a real-time state database to track prescriptions, and the arrests of pain doctors and dealers.

 

FDA panel votes no

A U.S. Food and Drug Administration advisory panel of experts in December voted 11-2 against approval of Zohydro ER because of concerns it would be abused. But the FDA -- which isn't bound by advisory opinions -- indicated in February the drug may still be allowed to reach the market, possibly as early as this summer.

An FDA spokeswoman declined to comment on Zohydro, manufactured by Zogenix, a San Diego drug company, or the agency's application review process.

Experts across the region and nation fear the drug would reach addicts and make a critical situation worse.

"Approval of this drug will worsen the epidemic of addiction and overdose deaths," said Dr. Andrew Kolodny, president of the national advocacy group Physicians for Responsible Opioid Prescribing, which presented its case against Zohydro to the FDA advisory panel.

Locally, police say they don't want another dangerous drug to contend with.

"The misuse or abuse of a new and even more powerful drug, like Zohydro, is a concern for everyone in law enforcement," said Suffolk County Police Deputy Chief Kevin Fallon.

Hydrocodone belongs to the opioid family of medications, a highly addictive group of drugs that includes morphine, codeine, methadone and oxycodone, which is the region's most abused drug.

Opioid pain pills designed to release a drug over time, like Zohydro, are often crushed and snorted by addicts seeking a stronger, immediate high. Purdue Pharma, the company that makes OxyContin, introduced a tamper-resistant form of the popular pill in 2010, making it harder to crush or dissolve, and experts say that has helped cut down on abuse.

"If Zohydro is released and it's not tamper-resistant, you're going to see . . . a situation that will take us back to the darkest days of this epidemic," said Dr. Thomas Jan, a Massapequa pain management and addiction specialist who serves on a Nassau County heroin abuse task force. "I won't prescribe it [if it's not tamper-resistant]. Everyone should be worried about this."

 

Tamperproofing urged

Sen. Charles Schumer (D-N.Y.) urged the FDA to deny approval of medications that are not tamperproof.

"If the FDA does approve these dangerous and potent products, they must require the manufacturers to make them tamperproof, or we risk a spike in addiction and prescription-drug-related crimes on Long Island and around the country," Schumer said.

The FDA missed a March 1 deadline on whether to approve Zohydro because it needed more time to review information about the drug, according to a statement issued by Zogenix. The stock price for Zogenix surged 40 percent the day the delay was announced.

The FDA has not provided Zogenix with information about the reason for the delay -- or requested any additional information from it -- but has indicated it may last only several weeks, the company said.

"We continue to believe the odds for eventual approval are high," Michael Tong, a Wells Fargo financial analyst, wrote in a recent note to clients. "We speculate FDA is dealing with issues of access and potential misuse."

In a March 15 earnings call with investors, Zogenix chief executive Roger Hawley said the company is readying for a potential commercial launch this year.

"We anticipate receiving an action letter from the FDA for Zohydro . . . in the near future after a delay of a few weeks," Hawley said in that call. "In an appropriate and conservative manner, we have continued preparations for a potential commercial launch, and should we receive approval, we anticipate bringing the product to market three or four months after the FDA approval."

In its literature, the company says Zohydro is a needed addition to the painkiller market because it would avoid the potential for liver injury stemming from long-term use of acetaminophen.

"We also understand the public health concerns regarding the misuse and abuse of all opioids and intend to be a proactive leader by implementing our proposed efforts to assure safe and appropriate use," said Stephen Farr, president and chief operating officer of Zogenix, in a statement.

The dangers of painkiller addiction on Long Island were highlighted in June 2011, when David Laffer killed four people during the robbery of a Medford pharmacy. Laffer and his wife, Melinda Brady, acquired nearly 12,000 pain pills -- including hydrocodone -- in the four years leading up to the crime. Both were heavy abusers of the medication, authorities said.

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