(Adds reaction, details on product)
By Susan Heavey
WASHINGTON, April 3 U.S. regulators on Thursday approved a portable device to treat painkiller overdoses that people without medical training can use in emergency situations, a move to combat the rise of deaths from the abuse of opioids, including heroin.
The Food and Drug Administration said making the cellphone-sized device with the recovery drug naloxone available for wider use could help save lives as opiod drug overdoses increase.
The approval means emergency responders or even family members could have an easy-to-use treatment 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.
More than 16,000 people die each year from prescription opioid overdose in the United States, according to the FDA and the device's maker, privately held drugmaker kaleo Inc.
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 hand-held device is called Evzio and automatically delivers a set dose of naloxone, a drug ingredient already approved to treat overdose patients that works by quickly restoring breathing.
Naloxone is now typically given through a nasal spray or a syringe that must be injected under the skin or into the muscle, and 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.
"Making this product available could save lives by facilitating earlier use of the drug in emergency situations," Bob Rappaport, head of the FDA division that reviews such products.
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 Envio 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 would 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. (Additional reporting by Natalie Grover in Bangalore; Editing by Michele Gershberg, Peter Cooney and Bernard Orr)