FDA approves first naloxone treatment to be given by caregivers to reverse opioid overdose

FDA has approved naloxone hydrochloride injection (Evzio, Kaléo, formerly Intelliject) for emergency treatment when opioid overdose is known or suspected because of respiratory and/or central nervous system depression.

Evzio rapidly delivers a single dose of the drug naloxone by means of a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet. Family members or caregivers can use the product to treat someone they think has overdosed on opioids.

Naloxone is well known to medical professionals and emergency medical services, who have used it for more than 4 decades to reverse respiratory depression resulting from opioid overdose.

“The approval is a correct step in the right direction,” said Tamar Elbaz, MD, of Pain Physicians NY. “In the meantime, the availability of a sort of  ‘over-the-counter’ opioid antidote may encourage further abuse,” she added, raising a criticism that has already been voiced by many.

He continued, “The benefits way outweighs the risks, though. I think formulary managers should add it to their list of covered medications. They should also make it mandatory for all patients on chronic opioid medications.”

Prolonged respiratory depression may result in damage to the central nervous system or death, so if opioid overdose is suspected, Evzio should be administered quickly.

The product employs voice and visual cues to guide a user through the injection process. However, family members or caregivers are directed to learn to use Evzio in advance of need. They can practice with a trainer device provided for that purpose with the actual product. 

Because naloxone may not be as long-acting as the effects of opioids, repeat doses may be needed. The product should not be considered a substitute for immediate medical care. Whoever administers Evzio should seek immediate medical attention on the patient’s behalf.

In one pharmacokinetic study of 30 patients, a single Evzio injection delivered an amount of naloxone equivalent to a single dose of naloxone injection administered through a standard syringe. Opioid-dependent patients who use Evzio may experience symptoms of severe withdrawal. Abrupt reversal of opioid depression may result in nausea, vomiting, sweating, accelerated heart rate (tachycardia), increased blood pressure, uncontrollable trembling (tremulousness), seizures, and cardiac arrest.

The FDA reviewed Evzio under the agency’s priority review program. 

More than 16,000 Americans die each year from prescription opioid overdose, and accidental drug poisoning, driven largely by prescription opioids, has surpassed automobile collisions as the leading cause of accidental death in the United States.

Evzio’s approval comes about as the result of efforts by several federal agencies. Naloxone has been a part of the White House’s Office of National Drug Control Policy’s National Drug Control Strategy since 2012. FDA co-chairs an HHS inter-departmental working group on naloxone, which helped coordinate an April 12, 2012, meeting regarding access to naloxone products.