FDA Approves Rezenopy (naloxone) for Emergency Treatment of Opioid Overdose

Not reported in label.

Rezenopy nasal spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. It is intended for immediate administration as emergency therapy in settings where opioids may be present and is not a substitute for emergency medical care.

Rezenopy nasal spray is for intranasal use only. The recommended initial dose in adults and pediatric patients is one spray delivered intranasally into one nostril. If the patient does not respond within 2 to 3 minutes or responds and then relapses into respiratory depression, an additional dose may be given into the other nostril with a new device. Repeat doses every 2 to 3 minutes as needed, alternating nostrils and using a new device each time, until emergency medical assistance arrives. Important instructions include: seek emergency medical care immediately after use, do not prime or test the device prior to administration, place the patient in supine position, support the back of the neck and tilt the head back, and turn patient on their side after administration. For partial agonists or mixed agonist/antagonists like buprenorphine, reversal may be incomplete and require higher doses or repeat administration.

Trial data not available in label.

Not reported in label.

Rezenopy nasal spray is an opioid antagonist for emergency treatment of opioid overdose, intended for use by non-patients in community settings. It requires immediate medical follow-up and may need repeat dosing due to opioid duration exceeding naloxone's effect. Additional supportive measures are recommended while awaiting emergency assistance.