FDA Approves Hand-Held Injector for Opiate Overdoses Amid Growing Epidemic

With more people in America today dying of drug overdoses than car accidents, the U.S. Food and Drug Administration (FDA) has approved an injectable antidote that can help bring an addict back from the brink.

Although the drug, called Naloxone, is already used by first responders, it requires a syringe and waiting for trained medical personnel to arrive.

Now, Naloxone comes in a hand-held injectable device called Evzio, similar to an Epi Pen used by those who suffer from deadly allergies. When a caregiver sees a person suspected of overdosing on heroin or prescription opioid medication begin to stop breathing, Evzio can temporarily halt the effects of the overdose.

Dr. George Fallieras, an emergency room physician at Good Samaritan Hospital in Los Angeles, Calif. said he frequently sees patients who overdose on opiates, including heroin, Oxycontin, and methadone.

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A 'Generation of Addicts'

He told Healthline that America has created a “generation of addicts” and that the new device will undoubtedly save lives.

In a statement to the news media on Thursday, FDA Commissioner Margaret A. Hamburg acknowledged the country's dire opiate addiction problem. The fast-track approval of Evzio came on the coattails of heavy criticism of the FDA for approving a pure hydrocodone drug called Zohydro ER last October.

Zohydro ER is an intensely potent, extended release painkiller. While the FDA approved it only for use in extreme cases, when other pain medications have failed to offer relief, doctors like Fallieras are skeptical and warn of the drug's serious potential for abuse.

“For more than a decade, the U.S. Food and Drug Administration has been working to address the important public health problems associated with the misuse, abuse, addiction, and overdose of opioid analgesics, while at the same time working to ensure continued access to effective and appropriate medications for millions of Americans currently suffering from pain,” Hamburg said in the statement. “I firmly believe that these goals are compatible, and that actions to address one should not be at the expense of the other.”

More than 16,000 people die each year from opioid overdoses, Hamburg said. But she noted that the FDA has taken steps to address the problem, including reclassifying hyrdocodone products from class 3 to class 2 controlled substances, making them harder to obtain.

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How Naloxone Works

Naloxone, the active ingredient in Evzio, is an opioid antagonist. It works by shutting off the brain's opiate receptors. By doing so, the drug causing the overdose no longer has any effect.

But Naloxone works suddenly and temporarily, Fallieras said. He and the FDA stressed that a caregiver would still need to seek immediate medical attention for the patient.

“The response is really dramatic, and it can be a little alarming,” Fallieras told Healthline. “These patients will have gone from sullen and unresponsive, to within a few seconds, eyes wide open and lurching forward.”

Although Evzio requires a prescription, deciding who to prescribe it to will need to be worked out, Fallieras said. “It would have to be for family members, roommates, other addicts to use on their friends and others.”

But whomever administers Evzio has to be ready for what's next. “Many are hooked, and it's like throwing them into immediate withdrawal,” Fallieras said. “They can get combative. They are very uncomfortable and in pain, but it saves their life.”

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Zohydro ER Approval 'Almost Criminal'

Fallieras does not mince words when it comes to talking about why the country needs a device like Evzio. He said a movement in the 1990s to consider pain “the fifth vital sign” led to the over-prescription of opiate medications.

“We have such an opiate epidemic. So many young people are dying from this," Fallerias said. "The numbers are increasing exponentially.”

He called FDA approval of Zohydro ER “almost criminal,” saying “we already have effective [pain] medications.”

Fallieras said very few individuals could use such a powerful medication. That it is available and carries such potential for abuse if it falls into the wrong hands is “absurd,” he said.

He called Vicodin a “gateway drug,” and said that such painkillers never should have been scheduled as class 3 drugs. He believes it is one of many factors that has led so many Americans down a path to painkiller addiction.

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A New Treatment for Alcoholics, Too

Fallieras also serves as medical director of Start Fresh Recovery, a program that uses a “cousin” of naloxone called naltrexone to treat alcoholics. Although naltrexone has been FDA-approved for many years, it only was available in pill form and had to be taken daily. 

Through a partnership with a company called BioCorRx, Fallieras gives naltrexone to patients in patch form. Although it is an opiate antagonist, it has also been proven effective in treating alcoholics, Fallieras said.

The program, featured earlier this year on television program The Doctors, includes intensive coaching. Fallieras believes patients have a better chance of succeeding during social therapy if they have a drug that helps ease physical withdrawals for an extended period.

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