(Refiles for typographical error in paragraph 14)
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,
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
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
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
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
"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
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
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
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
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
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
(Additional reporting by Natalie Grover in Bangalore; Editing
by Michele Gershberg, Peter Cooney and Bernard Orr)