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FDA Seeks to Balance Opioid Pain Needs With Addict Risks

December 18, 2012

Regulators will reopen debate over opioid painkillers next year as the U.S. government considers ways to reconcile the needs of patients suffering chronic ailments with the risks of addiction and recreational drug use.

The Food and Drug Administration plans a two-day public hearing starting Feb. 7 after receiving “comments, petitions, and informal inquiries concerning the extent to which opioid drugs should be used in the treatment of pain.” The meeting is intended to help understand how doctors define pain and measures used to limit opioid use, the agency said today in a statement.

The balancing act was highlighted two weeks ago when San Diego-based drugmaker Zogenix Inc. (ZGNX:US) failed to persuade FDA advisers to support approval of the first single-ingredient hydrocodone pill. While the company showed the medicine worked and presented patients from a trial who said the pill filled a need in the market, advisers at the Dec. 7 meeting were swayed by other stories of addiction and death.

“It is as complex an issue as I’ve seen in my 16 years at FDA,” Douglas Throckmorton, deputy director at the agency’s office that oversees drug reviews, said at a Dec. 10 conference in Washington. “They are the most commonly prescribed prescription drugs and they’re killing people.”

About 70 patient advocacy and health-care industry and provider groups are seeking to overcome the negative perceptions of painkillers by drawing attention to legitimate patients and their need for access to prescription opioids, which share many of the same narcotic traits as heroin.

‘Not Addicts’

There’s a difference between being addicted and needing pain medication to complete daily tasks just as someone with high blood pressure depends on their pills, said Paul Gileno, president of the Middletown, Connecticut-based U.S. Pain Foundation, in a phone interview. He said there’s a stigma pain patients deal with even though “we know we’re not addicts.”

“If it’s safe for us to use, we want it to be available for us so that it can help our pain,” said Gileno, who broke his back at his catering business in 2003. “Overdose is horrible and we don’t want to see that. We also want access.”

Some group members, including Gileno’s foundation, support approval of Zogenix’s pure hydrocodone Zohydro. Other advocates such as the American Academy of Pain Management, based in Sonora, California, don’t support new painkillers without tamper-resistant formulations that prevent the pills from being crushed and snorted for a greater high, said Bob Twillman, director of policy and advocacy for the group.

Tamper Resistant

The FDA expects to release a guideline on developing tamper-resistant formulations next month, Throckmorton said. The FDA will decide by March 1 if it will follow the panel’s advice to block approval of Zogenix’s pill because of the risk of abuse. Zogenix is researching a tamper-resistant version.

Endo Health Solutions Inc. (ENDP:US) makes an extended-release oxymorphone called Opana that is tamper resistant. The Chadds Ford, Pennsylvania-based company took its earlier version of Opana without the abuse deterrent off the market. Now Endo is suing the FDA to force the agency to say the earlier version was unsafe for sale, a determination that would mean generic competition can’t be cleared unless they’re tamper resistant as well, said Blaine Davis, a spokesman for the company.

A hearing is set for tomorrow, Shibani Malhotra, an analyst at RBC Capital Markets in New York, said in a note to clients.

Impax Laboratories

FDA’s announcement of the February opioid meeting indicates Impax Laboratories Inc. (IPXL:US), based in Hayward, California, will be able to bring its non-tamper resistant, generic version of Opana to market in January, Malhotra said. Impax’s product will only be available temporarily, Malhotra said, as the FDA will eventually find a way to prevent non-tamper resistant generics.

The FDA is considering two aspects of the opioid debate: single-ingredient pills such as oxycodone and hydrocodone; and combination pills like acetaminophen mixed Vicodin, which are sold in lower doses and have fewer regulations.

Hydrocodone combinations are the most popular pharmacy drugs in the U.S. with more than 130 million dispensed prescriptions last year, according to IMS Health, a Parsippany, New Jersey-based data company. The pills were also responsible for 115,739 overdose-related emergency room visits in 2010, double the tally in 2004, according to the Substance Abuse and Mental Health Services Administration.

Drug Schedules

Advisers to the FDA will meet Jan. 24-25 to discuss the risks and benefits of hydrocodone combinations used as pain relievers or cough suppressants. The Drug Enforcement Administration asked the FDA, which regulates pharmaceutical sales, to recommend stricter regulations on those painkillers.

The DEA is seeking to change drug classifications in a way that would require more interaction with doctors in order for people to obtain those combination products.

Members of the pain forum wrote Congress last month asking lawmakers to convene a task force from the Department of Health and Human Services or a think tank to come up with ideas to coordinate the government’s efforts to stem opioid abuse.

“While appropriate policies must empower law enforcement officials to act aggressively against individuals and entities actually engaging in diversion or abuse, diversion/abuse control actions must be balanced against the needs of health-care providers to provide care to legitimate patients,” the organizations, including the U.S. Pain Foundation and the American Academy of Pain Management, wrote Nov. 7.

DEA Crackdown

The biggest roadblocks have come from the DEA, said Kevin Nicholson, vice president of government affairs and public policy for the National Association of Chain Drug Stores. The association, a Washington-based lobby group for companies such as CVS Caremark Corp. (CVS:US), is part of the coalition with the patient advocates and also signed onto the letter.

The DEA has cracked down on retail pharmacies and drug distributors that sell high amounts of controlled substances, Nicholson said in a telephone interview.

A Walgreen Co. (WAG:US) distribution center was blocked from shipping controlled substances in September after it was determined to be a threat to public safety. The facility was the largest distributor of oxycodone products in Florida since 2009, the DEA said.

The pharmacy group said it supports prescription drug monitoring programs that have been implemented or are being put in place in every state except Missouri. They want a commission to figure out how to use the information, currently being collected by each state, more effectively.

In New York, Attorney General Eric Schneiderman touted monitoring legislation he proposed when his office arrested a doctor in Westchester who allegedly sold $450,000 worth of oxycodone to a drug dealer. The measure passed in June creates an Internet tracking system for controlled substances that doctors review and update when prescribing patients powerful painkillers.

The forum has gotten mixed responses from Congress, Nicholson said.

“We’re hopeful that it will lead to something more,” he said.

To contact the reporter on this story: Anna Edney in Washington at

To contact the editor responsible for this story: Reg Gale at

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