LOS ANGELES — Opioid drug overdoses, the cause of some 16,000 fatalities and half a million visits to emergency departments yearly, may have met their match: The Food and Drug Administration on Thursday approved the sale, by prescription, of a hand-held auto-injector of the opioid-reversal drug naloxone, a “rescue pen” that caregivers or family members can use to avert a potentially fatal overdose.
Delivered by syringe, naloxone has been a workhorse drug in emergency departments battling the relentless rise of opioid abuse in the last decade. The FDA’s blessing, granted after a deliberation of just 15 weeks, marks the first time the medication is to become available in a prefilled hand-held auto-injector to be used outside a hospital setting.
The device, to be marketed under the commercial name Evzio and produced for the Richmond, Va., firm Kaleo Inc., is modeled on devices like those that deliver epinephrine to patients with anaphylactic reactions, or insulin to diabetics. But like an automated external defibrillator, the Evzio kit also provides verbal instruction in the use of the injection for caregivers or family members who recognize the dangerously slowed heartbeat, depressed respiration and loss of consciousness that suggests someone taking opioids has overdosed. A training device allows caregivers and family members to practice emergency administration of 0.4 mg. of naloxone, which can be injected into muscle or just under the skin.
Making this product available for use beyond an ambulance or hospital “could save lives by facilitating earlier use of the drug in emergency situations,” said Dr. Bob Rappaport, director of the division of anesthesia, analgesia and addiction products at the FDA’s Center for Drug Evaluation and Research.
The use of Evzio is not without risks. Among the opioid-dependent, a shot of naloxone can cause sudden and severe opioid withdrawal, which can cause nausea, vomiting, accelerated heart rate, increased blood pressure, seizures and cardiac arrest.
Repeat doses may be needed, as opioids can outlast naloxone’s reversal effects, and the FDA cautioned that Evzio is not a substitute for emergency medical care.