Pubdate: Fri, 04 Apr 2014
Source: Washington Post (DC)
Copyright: 2014 The Washington Post Company
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Details: http://www.mapinc.org/media/491
Author: Brady Dennis
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DEVICE TO COMBAT OVERDOSES APPROVED

FDA Quickly Signs Off on Evzio, Which Injects an Antidote for Opioids

In a move aimed at stemming the tide of deaths caused by the nation's 
prescription drug epidemic, the Food and Drug Administration on 
Thursday approved a new device that would allow family members or 
caregivers to administer emergency medication to combat an overdose.

The product, Evzio, rapidly delivers a dose of naloxone, a longused 
antidote to overdoses of a powerful class of painkillers known as 
opioids, which include legal drugs such as Vicodin and OxyContin, as 
well as illicit drugs such as heroin. The treatment would be 
administered through a hand-held automatic injector that, when 
activated, gives spoken instructions to the user and is small enough 
to carry in a pocket.

Federal officials fast-tracked the approval of Evzio - the FDA 
reviewed its application in less than four months - saying it could 
play a critically important role in preventing some of the estimated 
16,000 annual deaths attributed to prescription drug overdoses, a 
problem that has grown steadily worse over the past decade.

Opioid overdoses are marked by slowed breathing, extreme fatigue and 
changes in heart rate. Because victims tend to lose consciousness and 
fall ill quickly, allowing nearby family members or caretakers to 
administer naloxone rather than waiting on paramedics or doctors 
could mean the difference between life and death.

"For years, the lack of a lay-friendly delivery system has made it 
difficult to make naloxone broadly available to the public and to 
foster its use in non-medical settings, where it is often most 
urgently needed," FDA Commissioner Margaret A. Hamburg told reporters 
Thursday, calling Evzio "an extremely important innovation that will 
save lives."

Regulators warned that Evzio should not be considered a substitute 
for medical care, that it works only temporarily to reverse overdose 
effects, and that it can trigger opioid withdrawal symptoms, 
including nausea, vomiting, sweating, uncontrollable trembling, and 
increased heart rate and blood pressure.

Still, the approval of Evzio will for the first time allow people 
with no medical knowledge to inject the drug into a patient's muscle 
or under the skin during an emergency by walking them through each 
step verbally, much like an automated defibrillator.

Family members or caregivers will need to get a prescription for the 
product ahead of time. But doing so would allow them to have a 
portable dose of naloxone in an easy-to-use injector about the size 
of a credit card and the thickness of a cellphone.

"This is an important milestone for the millions of patients taking 
opioids who are trying to balance pain management with the safe use 
of opioids, as well as those who are struggling with abuse," Eric 
Edwards, chief medical officer of Kaleo, the maker of Evzio, told 
reporters Thursday. "What we've realized is that opioid overdoses do 
not discriminate. . . . We want to make sure this product is made 
available to all who could benefit from it."

Company officials said they have yet to set a price for the device, 
in part because the FDA approval came so rapidly. But chief executive 
Spencer Williamson said the company will try to make sure opioid 
users have access to it, "regardless of their ability to pay."

The FDA used Thursday's approval as an opportunity to underscore 
other actions the government has taken in recent years to combat 
opioid misuse and abuse that has crippled communities throughout the 
country. Those efforts include altering the labeling of certain 
opioid drugs, requiring manufacturers to conduct longterm studies 
about the safety of their drugs and encouraging development of 
tamper-resistant forms of existing opioids and new pain treatments 
that are not so addictive.

At the same time, the FDA faces criticism for not doing more, and for 
potentially allowing the overdose epidemic to grow worse. The agency 
encountered opposition to its approval last fall of a new opioid, 
Zohydro, the first prescription narcotic comprising a pure dose of 
hydrocodone. Officials in Massachusetts last month blocked sales of 
the drug, with Gov. Deval L. Patrick (D) citing a public health emergency.

Although the FDA agreed with the drug's manufacturer that the pure 
hydrocodone formulation allows chronic pain sufferers to use the drug 
over the long term without the risk of liver damage, critics have 
warned that such a formulation makes the drug easier to abuse. Last 
month, the manufacturer of another opioid drug, OxyContin, said it 
plans to seek FDA approval for a tamper-resistant form of hydrocodone 
that would be less prone to abuse.

Various states, their economies battered and their workers hampered 
by addiction, have taken aggressive measures in fighting prescription 
drug abuse. They include tighter drug monitoring programs, stricter 
"doctor shopping" laws, increased treatment and counseling and 
intensified law enforcement efforts to crack down the illicit sale of 
prescription drugs. Some police agencies have equipped officers with 
naloxone in an effort to get treatment to users suffering an opioid 
overdose before paramedics arrive.

Some medical providers have expressed worry that Evzio could create a 
false sense of security among heavy opioid users, but the reaction to 
Thursday's approval by the FDA was overwhelmingly positive among 
health-care providers and addiction groups.

Knox Todd, a Texas emergency room physician who spoke on a call 
organized by Evzio's manufacturer, said the approval will create an 
even better opportunity to prevent many overdoses from becoming 
deadly. "This will expand the availability of what we know is a 
life-saving drug," he said, "to a larger population who can use it."
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MAP posted-by: Jay Bergstrom