US approves handheld opioid antidote device

A new handheld device that can quickly deliver a life-saving antidote for opioid overdose, including heroin and prescription painkillers, has been approved by the US Food and Drug Administration (FDA).
The first prescription treatment can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose.
The device called Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet, FDA said.
It is intended for the emergency treatment of known or suspected opioid overdose, characterised by decreased breathing or heart rates, or loss of consciousness.

Drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the US - surpassing motor vehicle crashes, FDA said.
Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for overdose.

However, existing naloxone drugs require administration via syringe and are most commonly used by trained medical personnel in emergency departments and ambulances.
"Overdose and death resulting from misuse and abuse of both prescription and illicit opioids has become a major public health concern in the US," said Bob Rappaport, director of the Division of Anaesthesia, Analgesia, and Addiction Products in the FDA's Center for Drug Evaluation and Research.

"Evzio is the first combination drug-device product designed to deliver a dose of naloxone for administration outside of a health care setting. Making this product available could save lives by facilitating earlier use of the drug in emergency situations," said Rappaport.
Evzio is injected into the muscle (intramuscular) or under the skin (subcutaneous). Once turned on, the device provides verbal instruction to the user describing how to deliver the medication, similar to automated defibrillators.
Because naloxone may not work as long as opioids, repeat doses may be needed, FDA said.
Evzio is not a substitute for immediate medical care, and the person administering Evzio should seek further, immediate medical attention on the patient's behalf.

In one pharmacokinetic study of 30 patients, a single Evzio injection provided equivalent naloxone compared to a single dose of naloxone injection using a standard syringe.
The use of Evzio in patients who are opioid dependent may result in severe opioid 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.