Evzio™ – New Naloxone Auto-Injector For Opioid Overdose

By: Diana Gritsenko, PharmD Candidate c/o 2015

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Drug overdose is a serious problem in the United States.  In 2010, drug overdose caused more deaths among adults within the ages of 25 and 64 years than motor vehicle accidents. The Center for Disease Control (CDC), ran an analysis that showed drug overdose death rates have been steadily rising since 1992, with a 102% increase from 1999 to 2010.¹ This increase in overdose related deaths runs parallel with a 300% increase in the sale of prescription painkillers (opioids) since 1999.² To help control and lower the risk of death, the Food and Drug Administration (FDA) approved naloxone hydrochloride auto-injector, Evzio™, as a take-home antidote for opioid overdose. It was granted a fast-track designation under the FDA’s priority review program, which was created in order to expedite the review of drugs that fill an unmet medical need.³

Naloxone hydrochloride is an opioid antagonist that has a great affinity for the mu, kappa, and sigma receptors in the central nervous system.  It is used for the reversal of life-threatening respiratory depression caused by opioid overdose and has become standard treatment.  The previously existing forms of naloxone, such as Narcan, had to be administered by trained medical personnel typically in the emergency department or an ambulance. Now, patients, family members, and caregivers can administer naloxone by the intramuscular or subcutaneous route to both adults and children.³

Each prescription of Evzio™ will come with two Evzio™ auto-injectors (0.4mg naloxone each) and a black-and-white trainer that can be used over 1,000 times for practice.  Although the Evzio™ device comes with an automated voice that instructs users on how to administer the medication, practice with the trainer is still recommended. Certain opioids may have a longer half-life than that of naloxone. Therefore, it may be necessary to administer naloxone every 2-3 minutes while waiting for emergency medical help to arrive.  For this reason, patients are encouraged to speak to their prescribers regarding a refill of their prescription even if they have only used one auto-injector.⁴

There are a few considerations that should be addressed with Evzio™.  Evzio™ is administered to both adult and pediatric patients in the same way as an EpiPen^®– through the anterolateral aspect of the thigh. However, in pediatric patients under the age of one, it is necessary to pinch the thigh muscle while administering the drug in order to ensure that the drug is deposited into the muscle.⁴ In patients who are opioid dependent, abrupt reversal may precipitate a severe opioid withdrawal. Although opioid withdrawal in general is not life threatening, it is very uncomfortable. Patients can experience agitation, anxiety, muscle aches, insomnia, sweating and a host of other symptoms.⁵ A final consideration involves those patients who present with opioid overdose due to buprenorphine, pentazocine, or other partial opioid agonists. In these patients, the administration of naloxone may produce an incomplete reversal of respiratory depression. Additionally, larger doses and longer duration of administration of naloxone are required for buprenorphine, due to its long duration of action and subsequent slow dissociation from the opioid receptor.⁴

      Evzio™ is the first handheld auto-injector made available to patients and caregivers for the treatment of opioid overdose.  While it may be too early to assess the impact of this medication, it is important to counsel patients and their loved ones on the signs/symptoms of opioid overdose, the proper administration of the medication, and the importance of seeking emergency medical help.

SOURCES:

1. Prescription drug overdose in the United States: fact sheet. Centers for Disease Control and Prevention website. http://www.cdc.gov/homeandrecreationalsafety/overdose/facts.html. Updated February 10,2014. Accessed May 1, 2014
2. Policy impact: prescription painkiller overdoses. Centers for Disease Control and Prevention website. http://www.cdc.gov/homeandrecreationalsafety/rxbrief/. Updated July 2,2013.  Accessed. May 1,2014.
3. FDA approves new handheld auto-injector to reverse opioid overdose. Food and Drug Administration website. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391465.htm. Updated April 3,2014.  Accessed May 1,2014.
4. Evzio™[package insert] Richmond, VA: Kaleo, Inc; 2014.
5. Opioid Withdrawal. MedlinePlus: a service of the U.S. National Library of Medicine National Institutes of Health website. http://www.nlm.nih.gov/medlineplus/ency/article/000949.htm. Updated January 23, 2012.  Accessed May 1,2014.

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