Two members of Maine’s congressional delegation are pressuring federal regulators to revoke approval of a new painkiller that’s among the most powerful on the market.
Congressman Mike Michaud and Congresswoman Chellie Pingree signed a letter in December to U.S. Food and Drug Administration Commissioner Margaret Hamburg asking her to reconsider approval of the narcotic Zohydro ER, awarded last year despite warnings from the agency’s own panel of experts that the drug was prone to abuse.
As a crushable pill, Zohydro can be snorted or injected. Some experts contend it’s much more likely to be abused than other drugs, such as OxyContin, which was reformulated in 2010 to make it tamper-resistant.
Zohydro includes high doses of an opioid painkiller, similar to OxyContin. According to the drug company’s literature, an adult could overdose on two capsules and swallowing just one pill could kill a child, NPR reports. The drug is the first ever cleared for U.S. patients that contains only the opioid hydrocodone, and at a dose five to 10 times higher than Vicodin and similar painkillers that blend hydrocodone with over-the-counter pain relievers such as acetaminophen or ibuprofen.
“New England has seen more than our share of prescription drug addiction and abuse,” Pingree said in a statement. “One effective response has been to make pain killers like OxyContin tamper resistant but now the FDA has gone ahead and improved a new drug that doesn’t have those safeguards. It just doesn’t make sense and even the FDA’s own experts warned against approving the drug.”
The FDA’s medical advisory panel recommended 11-2 against approving the drug.
Pingree and Michaud joined U.S. House colleagues Reps. Carol Shea-Porter and Annie Kuster of New Hampshire, and Rep. Peter Welch of Vermont in sending the letter.
Zohydro’s manufacturer has announced it’s developing a tamper-resistant version of the drug, due to hit the market in three years. Pingree and her colleagues called on the FDA to keep the drug off the market until the new form is available, according to her statement. Attorneys general from more than two dozen states, including Maine, have made the same request.
Otherwise, Zohydro is due to become available within the month, according to Michaud’s office.
Michaud joined a bipartisan group of lawmakers in introducing legislation to withdraw FDA approval of the drug. The bill, An Act to Prohibit Zohydro, also would prohibit the FDA from approving any version of the drug not formulated to prevent abuse.
“As the New England states continue to combat opiate addiction, the last thing our communities need is a new, highly abusable narcotic on the street,” Michaud said in a press release.
Randy Liberty, Kennebec County sheriff and president of the Maine Sheriffs’ Association, was quoted in Michaud’s release saying the legislation is crucial to prevent more overdose deaths.
He was joined by Darrell Crandall, Aroostook County chief deputy sheriff and former commander of the Maine Drug Enforcement Agency.
“Law enforcement in Maine has far too frequently witnessed the dire consequences of the improper use of high potency, delayed release opioids,” Crandall said in the release. “In my experience, the worst of those drugs failed to include adequate tamper resistant formulas.”
The Maine Chiefs of Police Association also announced support for the bill, the release states.
Dr. Brad Galer, chief medical officer for the drug company Zogenix, which is marketing Zohydro, told NPR the company will closely monitor any abuse of the medication, which he said could help millions of people in chronic pain.
The FDA has defended the drug amid growing calls from public health groups and others to rescind its approval.
“We recognize that this is a powerful drug, but we also believe that if appropriately used, it serves an important and unique niche with respect to pain medication and it meets the standards for safety and efficacy,” Hamburg said yesterday at a hearing of the U.S. Senate’s Health, Education, Labor and Pensions Committee, according to Reuters.
Correction: I reworked a sentence comparing Zohydro to OxyContin to reflect that Zohydro does not come in significantly higher doses.