Massachusetts Gov. Deval Patrick has declared a public health emergency in his state over the “growing opioid addiction epidemic” and ordered state health officials to take several steps to combat overdoses, help drug addicts and find a long-term solution to opiate abuse in Massachusetts.
One of his first steps is an unprecedented ban on Zohydro, the first pure hydrocodone painkiller sold in the U.S. Some addiction treatment experts have claimed that Zohydro – which came on the market just a few weeks ago – will fuel a new wave of narcotic abuse and overdoses.
“The introduction of this new painkiller into the market poses a significant risk to individuals already addicted to opiates and to the public at large,” the Governor’s office said in a statement.
Patrick’s order prohibits the prescribing and dispensing of any hydrocodone-only formulation until adequate safety measures are in place to safeguard against the potential for diversion, overdose and misuse. Zohydro was introduced without a tamper resistant formula to discourage addicts from snorting or injecting the drug.
San Diego-based Zogenix (NASDAQ:ZGNX), which makes Zohydro, said it was “extremely concerned” by the governor’s decision to ban a prescription medication that was approved by the Food and Drug Administration.
“We are disappointed that today legitimate severe chronic pain patients in Massachusetts received a serious blow in their efforts to find relief for the suffering that affects their – and their families’— daily lives,” Zogenix said in a statement. “Ultimately, the ban on the prescription medication will add to patient suffering in the state.”
Zogenix claims Zohydro is actually safer than other hydrocodone combination products, such as Vicodin, because it does not contain acetaminophen – which can cause liver damage at high doses.
Addiction treatment experts have claimed Zohydro is 5 to 10 times more potent than Vicodin and have warned it is more likely to be abused by drug addicts because it does not come in a tamper resistant formula.
Zogenix says Zohydro is being unfairly singled out.
“Over the last 12 months, more than 360,000 prescriptions for extended-release opioids were dispensed in Massachusetts, and a significant majority did not have FDA-approved abuse deterrent claims,” Zogenix said.
“We fail to see how banning the sale of a single new product will achieve the governor’s policy objectives when all of the products that are currently part of the epidemic remain available for sale in the state.”
Massachusetts is the first state to ban Zohydro. The FDA is under growing political pressure to reverse its decision to approve Zohydro over the objections of its own staff and advisory committee, which warned Zohydro could be abused even more than currently available hydrocodone products.
Senator Joe Manchin, a West Virginia Democrat has introduced a bill in Congress to force the FDA to withdraw its approval of Zohydro.
The increased use of hydrocodone, oxycodone and other narcotic painkillers is often blamed for a nationwide surge in heroin addiction. At least 140 people have died from suspected heroin overdoses in Massachusetts in the last several months. From 2000 to 2012, the number of accidental opiate overdoses in the state increased by 90 percent.
“We have an epidemic of opiate abuse in Massachusetts, so we will treat it like the public health crisis it is,” said Gov. Patrick.
In addition to the ban on Zohydro, Patrick ordered state health officials to allow paramedics and other first responders to carry Naloxone, a medication that can reverse the deadly effects of an opioid overdose.
Massachusetts will also require physicians and pharmacists to use the state’s prescription drug monitoring program to keep better track of the drugs that patients are using. This was previously a voluntary program.
The Governor’s office will also dedicate an additional $20 million to addiction treatment programs.
“We truly are in a state of emergency when it comes to opiate addiction, and the Commonwealth has had to do a lot with limited resources,” said Congresswoman Liz Malia. “Expanding services will fill some of the existing gaps in the system and allow those in need to access treatment in real time – when they need it and in the most appropriate setting.”
“Those of us who have spent our careers working in the addiction treatment field have never experienced anything that approaches the current opiate abuse epidemic,” said Chuck Faris, CEO of Spectrum Health Systems. “The pain inflicted on families, the increase in crime and the loss of lives is unprecedented.”