Learn about the first naloxone auto-injector approved by the FDA.

The questions below were asked by DoctorOz.com and answered by Dr. Eric Edwards, MD, PhD, chief medical officer of kaléo.

Why do you think a drug like EVZIO is so important to be available?

Sadly, deaths from drug poisoning, driven largely by prescription opioid pain medications, have surpassed car accidents as the leading cause of accidental death in the U.S. In fact, 67 people in this country die each day, on average, from prescription opioids or heroin. An opioid emergency, such as an opioid overdose, is characterized by breathing that slows to a dangerous rate or even stops. Small changes – such as an extra medication dose or the consumption of alcohol – can result in a potentially life-threatening opioid emergency. Without intervention, severe clinical consequences may occur within minutes as lack of oxygen can lead to brain injury in as little as four minutes while the average emergency medical response time in this country is over nine minutes. Since most opioid emergencies occur in the home, friends and family may be in the best position to intervene quickly.

Prescription opioid pain medications are an important part of the treatment of pain; however, life-threatening side effects can occur, even for those who are taking their prescription opioids as directed. That is why we developed EVZIO®, the only naloxone product that provides visual and voice instructions to help make it easy to administer naloxone during a stressful opioid emergency and the first naloxone product specifically designed and approved for use by laypersons such as caregivers and family members with little to no training. Studies demonstrate, on average, 94 percent of users can correctly administer EVZIO without training, and 100 percent with training.

EVZIO is a prescription medicine used for the treatment of an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond. The EVZIO naloxone auto-injector should be given right away by a caregiver and does not take the place of emergency medical care. After the first EVZIO is administered, one should seek emergency medical help right away, even if the person wakes up. In addition, patients should tell their healthcare provider about all of their medical conditions and the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements before getting a prescription for EVZIO.

During an opioid emergency, such as an accidental overdose, seconds count, and immediate treatment can be the difference between life and death.

What do you hope having EVZIO out on the market will accomplish?

Having FDA-approved prescription naloxone, such as EVZIO, for use in the community such as the home is extremely important. Over 135,000 opioid emergencies occur each year in those using heroin, in those who have an addiction to prescription opioids, and in those who use opioids for the treatment of pain as directed. This can occur when someone takes an opioid in combination with another drug (including alcohol or anti-anxiety medications such as benzodiazepines) or in the presence of certain medical conditions that contribute to slowing or stopping someone’s breathing such as severe asthma. Others in the household are also potentially at risk. For example, in 2011, 5,187 children aged five and under were admitted to emergency departments across the U.S. for accidental prescription opioid ingestions. For these reasons, Federal government agencies such as the Centers for Disease Control and Prevention (CDC) and the Substance Abuse and Mental Health Services Administration (SAMHSA), as well as professional organizations like the American Medical Association and American Society of Addiction Medicine encourage physicians to consider prescribing naloxone for patients taking opioid pain medications or with an opioid use disorder.

Three out of four insured Americans are covered for EVZIO. Based on the latest information, the median out of pocket cost for patients who have received EVZIO is less than $20 for a prescription that includes two auto-injectors and a trainer. Individuals with commercial insurance may be eligible to have EVZIO mailed directly to their home for a $0 copay. EVZIO is also covered broadly by government insurance plans including the U.S. Veterans Administration, Tricare and the majority of state Medicaid programs. For prescribing information and details on specific insurance plans, visit www.evzio.com.

What are the warning signs that someone may need to use EVZIO

If you have never seen a person have an opioid overdose, you may be worried that you won’t know how to recognize one. However, people without medical training can learn to identify an opioid overdose and when to use EVZIO. Warning signs of a potential opioid emergency include:

  • Extreme or unusual sleepiness
  • Breathing problems from slow or shallow breathing to not breathing at all
  • Unresponsiveness when you try to awaken them
  • Very small pupils (the black circles in the center of your eyes), also called "pinpoint pupils"
  • Slow heartbeat and/or low blood pressure
  • Blue or purple fingernails or lips

Most importantly, if you think a person is having an opioid emergency, such as an overdose—even if you're not quite sure—immediately administer EVZIO and call 911 or seek emergency medical assistance.

How can caregivers prepare themselves to use EVZIO?

People who are in treatment for a prescription opioid or heroin addiction or those managing pain with the help of opioids should talk to their healthcare provider about having naloxone in the home as encouraged by the American Medical Association for patients who are at risk so that friends, family members, or caregivers can rapidly intervene in the event of an opioid emergency. In addition, it is important to note that every prescription of EVZIO comes with a black-and-white Trainer that can be used for practice. To be prepared in an opioid overdose emergency, patients, family members, caregivers, and other individuals who may have to administer EVZIO should have an opioid emergency plan in place and practice using the Trainer to become familiar with the injection process.

For more information about EVZIO, and complete prescribing information, please visit www.evzio.com. Answers provided by Dr. Eric Edwards, MD, PhD.

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