“Rescue Pen” Averts Opioid Overdose Risk

The Evzio pen is modeled on similar devices used deliver epinephrine to patients with anaphylactic reactions, or insulin to diabetics. But the Evzio, much like an automated external defibrillator (AED), also provides vocal instructions for caregivers or family members who recognize the dangerously slowed heartbeat, depressed respiration, and loss of consciousness that suggests an opioid user has overdosed. Evzio is intended for intramuscular or subcutaneous administration into the anterolateral aspect of the thigh, through clothing if necessary. A training device is also available for practice.

The use of the device, however, is not without risks, such as sudden and severe opioid withdrawal, which can cause nausea, vomiting, accelerated heart rate, increased blood pressure, seizures and cardiac arrest. Additionally, in some cases, repeat doses may be needed, as opioids can outlast naloxone's reversal effects. The Evzio autoinjector formulation of naloxone is a product of kaléo (Richmond, VA, USA), and has been approved by the US Food and Drug Administration (FDA; Silver Spring, MD, USA), under a fast-track status, which negates the need for an advisory committee.

“Kaléo was founded on the idea that patients are true experts on how their conditions impact their lives, and Evzio was developed with patient and caregiver input throughout to make sure it would be easy to use in stressful opioid emergencies with limited training,” said Eric Edwards, MD, PhD, chief medical officer of kaléo. “Immediate availability of Evzio for family members and caregivers to administer during a suspected opioid overdose has the potential to save many lives.”

“Anyone at risk for overdose can obtain a prescription for the drug, as can family members or caregivers of those at risk,” said Douglas Throckmorton, MD, deputy director for regulatory programs at the FDA Center for Drug Evaluation and Research, who emphasized that the final direction is to seek medical care. “We don't want people to have the sense that this is the last thing they need to do; they need to get help.”

Naloxone is used to counter the effects of opioid overdose, for example heroin or morphine, and is specifically used to counteract life-threatening depression of the central nervous system (CNS) and respiratory system. Naloxone has been used for more than 40 years for reversal of respiratory depression due to opioid overdose, but has been primarily used by emergency medical services (EMS) in injection form.

Related Links:
kaléo
FDA