On Thursday, regulators at the U.S. Food and Drug Administration approved a portable device to treat opioid overdoses that people without medical training can use in emergency situations. The approval comes in response to the rise of deaths from the abuse of opioids, including heroin.
The Food and Drug Administration (FDA) said making the portable, cellphone-sized device with the recovery drug naloxone available for wider use could help save lives as opioid drug overdoses increase.
The approval means emergency responders or even family members could have an easy-to-use antidote in cases of suspected overdose of opioids, which include pain drugs like oxycodone, morphine, codeine and hydrocodone as well as heroin.
“It’s really an effort to make this very usable,” FDA Commissioner Margaret Hamburg said.
According to the Centers for Disease Control and Prevention (CDC), drug overdose death rates in the U.S. have more than tripled since 1990. More than 12 million people reported using prescription painkillers nonmedically (i.e., using them without a prescription or using them only for the feeling they cause) in 2010. These drugs were involved in 14,800 overdose deaths in 2008. Methadone, a drug commonly prescribed to treat withdrawal symptoms among heroin addicts, accounts for only 2 percent of all painkiller prescriptions in the U.S. but is responsible for a staggering one-third of all prescription painkiller overdose deaths.
The number of heroin users in the U.S. jumped almost 80% to an estimated 669,000 in 2012 from 373,000 in 2007, according to surveys by the Substance Abuse and Mental Health Services Administration, part of the Department of Health and Human Services. Annual overdose deaths attributed to heroin hit 3,094 in 2010, the most recent data available, up 55% from 2000, said the Centers for Disease Control and Prevention.
Opioid overdoses are mostly tied to those addicted to painkillers and heroin, but they can also happen accidentally in patients using the prescription medicines legitimately to treat pain.
The newly-approved hand-held device, called Evzio, automatically delivers a set dose of naloxone, a drug ingredient already approved to treat overdose patients that works by quickly restoring breathing.
Currently, Naloxone is typically given through a nasal spray or a syringe that must be injected under the skin or into the muscle, but its use has been limited mostly to medical professionals at hospitals and emergency rooms as well as a growing number of police officers and other emergency responders.
The version approved on Thursday is small enough to be carried in a pocket, the FDA said. Relatives and caregivers would still need training and practice on how to use the device, and several doses may be needed to revive someone, the agency added.
“Overdose and death resulting from misuse and abuse of both prescription and illicit opioids has become a major public health concern in the United States,” said Bob Rappaport, M.D., director of the Division of Anesthesia, 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.”
HEALTH EXPERTS WELCOME MOVE
The FDA’s Hamburg said that while wider use of overdose treatment was important, “the larger goal is to reduce the need for products like these by preventing opioid addiction and abuse.”
Health experts and other advocates trying to combat the effects of drug addiction welcomed the device’s approval in a conference call with the FDA, and some even suggested doctors prescribe it along with initial opioid painkiller prescriptions.
But some also worried the injector could cause some people to dismiss the risks of opioid use because an antidote would be easier to access.
FDA and other federal drug officials said Evzio was not a substitute for medical care and that it was essential that people who overdose still get quick medical attention.
It was not immediately clear how much the injector would cost or whether health insurance companies, including the government’s Medicare and Medicaid programs, would cover it.
The device will require a prescription and will be available at pharmacies this summer, the company said, adding it had not yet set a price.
Meghan Ralston of the Drug Policy Alliance advocacy group, expressed concern in a statement about costs and said people should use “whichever form of naloxone is most convenient and affordable for them.” She called on manufacturers to ensure affordability.
A growing number of municipalities have stocked other naloxone treatments and have begun training firefighters, police officers and other emergency medical personnel on how to deliver the antidote.
Separately on Thursday, New York Attorney General Eric Schneiderman said the state would equip every law enforcement officer in the state with naloxone to help fight a surge in heroin overdoses. The effort will be funded with $5 million recovered from drug traffickers.
Schneiderman cited data from police in Quincy, Massachusetts, which began requiring officers to carry naloxone in 2010. Since that time, the police department has used the drug 221 times and reversed overdoses in 95 percent of those cases.
Last week, Massachusetts Governor Deval Patrick, in a speech declaring a public health emergency stemming from the abuse of opioids, said his state would also make naloxone more widely available.
The device’s approval comes just weeks after Attorney General Eric Holder said that the recent spike in heroin overdoses is an “urgent and growing public health concern.”
“Confronting this crisis will require a combination of enforcement and treatment. The Justice Department is committed to both,” said Holder.
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