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Sheena Harrison

FDA approves opioid overdose remedy as comp industry prepares for Zohydro

April 3, 2014 - 3:43pm


The U.S. Food and Drug Administration has approved a new medication that it says will be critical in preventing opioid painkiller overdoses -- one of the top pharmaceutical issues that the workers compensation industry continues to keep an eye on.

In a statement Thursday, the FDA announced that it has approved Evzio, a prescription treatment that can be used by family members or caregivers to treat people who have overdosed on opioid medications. The medication, naloxone hydrochloride, is delivered through a handheld auto-injector.

While naloxone has been used by first responders and hospitals to treat prescription overdoses, Evzio marks the first time that such a remedy will be available outside of a health care setting, the FDA said.

"This product is the first auto-injector designed to rapidly reverse the overdose of either prescription or illicit opioids," FDA Administrator Margaret A. Hamburg said in a statement Thursday. "While the larger goal is to reduce the need for products like these by preventing opioid addiction and abuse, they are extremely important innovations that will help to save lives."

Naloxone "reverses the severely slowed breathing that can lead to death during an overdose," said Dr. Douglas C. Throckmorton, FDA deputy center director for regulatory programs, in a blog post Thursday. "When naloxone works, the results can be dramatic: Comatose patients can wake up in minutes."

Richmond, Va.-based Kaleo, Inc., which manufactures Evzio, said it expects the remedy will be available this summer "through all major pharmacies and via mail order with a healthcare professional's prescription."

Evzio's approval, which was fast-tracked by the FDA, comes just as a new opioid medication is causing a stir among observers concerned about increased instances of opioid addiction and overdoses among users.

Zohydro ER was approved by the FDA in October and was released to the market last month. The extended-release pill, which contains 10 to 50 milligrams of hydrocodone, is classified by the FDA as a Schedule II controlled substance, meaning it can only be dispensed with a doctor's prescription and that refills are not allowed.

There has been some swift reaction to Zohydro's release. Massachusetts Gov. Deval Patrick declared a public health emergency in his state last week related to opioid painkiller abuse, and banned prescribing and dispensing of Zohydro "until determined that adequate measures are in place to safeguard against the potential for diversion, overdose and misuse."

For its part, Zohydro manufacturer Zogenix Inc. said Gov. Duval's actions would "unfairly restrict patient access to the only hydrocodone pain reliever available for long-term, daily, severe chronic pain patients," particularly for those at risk of acetaminophen toxicity from their current medications. The San Diego-based pharmaceutical company also contends that Zohydro is "no more potent than any other hydrocodone medication available."

Workers comp industry experts have said they expect to see Zohydro appear in workers comp claims, adding to concerns about injured workers who already face health risks from taking powerful medications such as OxyContin, the opioid pill Opana, or Actiq, a painkiller lollypop that contains the potent narcotic fentanyl.

In several recent conversations I've had with workers comp experts, many say that the problem of opioid addiction and overdose continues to rear its ugly head in myriad ways throughout comp -- despite the industry's best efforts to help injured workers heal without becoming dangerously dependent on such medications.

As the industry continues to develop pharmaceutical management strategies for Zohydro and other potent medications, perhaps Evzio will be a key tool to help curb prescription drug-related tragedies.