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FDA Approves Naloxone Auto-Injector for Opioid Overdose

Darrell Hulisz, RPh, PhamD
Associate Profess

May 1, 2014

Mortality related to drug overdose is currently the leading cause of injury death in the United States, surpassing motor vehicle accidents.1 This issue matter has been a trending issue for many years as the Centers for Disease Control and Prevention declared the rate of drug overdose-related deaths has been growing for over a decade.

The FDA announced the approval of Evzio® on April 3, 2014 which is the first naloxone treatment meant for a caregiver to administer to an individual suffering from an opioid overdose. This single dose (0.4mg) pre-filled, hand-held naloxone auto-injector is intended to be injected intramuscularly, preferably in the anterolateral portion of the thigh, for emergency situations only. Naloxone is the standard of care for opioid overdose and has the potential to rapidly reverse opioid toxicities. Common symptoms of opioid overdose include a diminished breathing rate, heart rate, and level of consciousness. Traditionally, naloxone administration required trained personnel, which is frequently an issue as these professionals are oftentimes not the first responders. It should be noted that emergency medical care is necessary in situations of opioid overdose even following the administration of Evzio® as many complications can arise such as opioid withdrawal. Additionally, opioids generally have a longer duration of action than naloxone. Careful monitoring is especially critical for children less than one year of age. Please refer to the package insert for a listing of adverse reactions.

Family members and/or caregivers of opioid users should be adequately trained on the administration technique for Evzio® to allow for effective administration if an emergency arises. Evzio, which received fast-track designation by the FDA, offers the potential to be a life-saving reversal agent for many opioid overdoses.

1. FDA approves new hand-held auto-injector to reverse opioid overdose. Retrieved from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391465.htm.

2. Evzio [prescribing information]. Kaleo, Inc. Richmond, VA. Available at: http://evzio.com/hcp/

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