What Does the FDA's Approval of Evzio Mean for You and Your Patients?

On April 3, 2014, the US Food and Drug Administration (FDA) approved Evzio (naloxone hydrochloride injection) for the emergency treatment of known or suspected opioid overdose. The FDA had granted Evzio fast-track approval status, and took only 15 weeks to review the application.

By summer, this hand-held auto-injector device will be available for use in the US. The device, much like commonly available automatic external defibrillators (AEDs) will give voice commands that provide step-by-step directions for proper use. It is hoped that the Evzio auto-injector will save thousands of lives; currently, more than 16,000 American die each year from opioid poisoning. Based on this, the approval of Evzio and the manufacturer’s commitment to making it available to all who could benefit from it is outwardly a good idea.

But, before you start prescribing this device for every patient to whom you prescribe opioids, remember that intravenous naloxone antagonizes opioid effects in 60-90 seconds, but intramuscular naloxone will several minutes or longer to be effective. Depending upon the amount of opioid consumed, the depth of the resulting opioid-induced respiratory depression, and other mitigating factors, it may not be possible for Evzio to save everyone who receives it.

Ideally, the person who administers Evzio to a patient who has overdosed on opioids can provide rescue breathing or cardiopulmonary resuscitation (CPR) long enough for the naloxone to take effect. I can imagine someone having respiratory depression, then cardiac arrest, receiving Evzio administered without effect.

There are many unanswered questions surrounding this product that will need to be addressed. To whom should Evzio be prescribed? To all patients legitimately using opioids for pain control? To patients deemed to be at high risk for opioid abuse or misuse? To all potentially “at-risk” teenagers and those in their early twenties because they may be more likely to abuse prescription opioids? To all emergency responders (eg, police, fire, ambulance services and airline flight crews)? How will consumers be educated about the proper use of the device? Is the use of Ezvio ever contraindicated (eg, in the palliative care/hospice setting)?

Already some pain practitioners have expressed concern that readily available Evzio may encourage some people to abuse opioids more aggressively believing that the device will provide a margin of safety. There is some concern that the availability of Evzio will deter the FDA from its current focus on “hardening” opioids to make it more difficult to abuse and misuse them, and potentially encourage the agency to allow opioids with no abuse-deterrent features to remain available despite concerns about their safety.

There is no “magic bullet” for the current opioid problem. Tragically, there is still widespread undertreatment of pain in the US even at a time when more people die from opioid misadventures than ever before. Improved practitioner and consumer education is still needed, but this remains voluntary at best even though there are millions of potential opioid “abusers” in our country.

Complex problems will not be solved with single strategies; they will require multifactorial solutions. Clinicians should view Evzio as one potential tool, not as the “holy grail” of preventing death from opioid overdose. Continue to evaluate each patient for opioid therapy on an ongoing basis, realizing that “risk” changes through time.

B. Eliot Cole, MD, MPA, is a member of the Pain Management editorial advisory board. He has served in executive positions for several prominent pain management organizations and societies, including the American Society of Pain Educators and the American Academy of Pain Management. He has been a pain management fellow, clinician, educator, and advocate for nearly 30 years and has practiced in a variety of settings serving a wide range of patients.