Rezenopy FDA Approval History
Last updated by Judith Stewart, BPharm on May 2, 2024.
FDA Approved: Yes (First approved April 19, 2024)
Brand name: Rezenopy
Generic name: naloxone hydrochloride
Dosage form: Nasal Spray
Company: Summit Biosciences Inc.
Treatment for: Opioid Overdose
Rezenopy (naloxone hydrochloride) nasal spray is an opioid antagonist 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.
- Rezenopy nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. Rezenopy nasal spray is not a substitute for emergency medical care.
- Overdose deaths remain a leading cause of injury-related death in the United States. The majority of overdose deaths involve opioid drugs, which include the illegal drug heroin, synthetic opioids such as fentanyl, and prescription pain relievers such as oxycodone (OxyContin), hydrocodone, codeine, and morphine.
- Naloxone is an opioid antagonist that has been used for decades to safely and effectively reverse opioid overdoses. Naloxone works to reverse an opioid overdose by competing for the mu, kappa and sigma opiate receptor sites in the CNS to block the effects of opioids. Naloxone can restore normal breathing within 2 to 3 minutes in a person whose breathing has slowed or stopped as a result of opioid overdose.
- Rezenopy is a high dose formulation containing 10 mg of naloxone per spray, and is available on prescription. There are a number of naloxone hydrochloride nasal spray products available that contain a lower dose of naloxone, including Kloxxado (8 mg/spray) and Rextovy (4 mg/spray) which are available on prescription, and Narcan (4 mg/spray) and ReVive (3 mg/spray) which are available over-the-counter.
- Rezenopy is administered as a single spray intranasally into one nostril in adult and pediatric patients. 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. No more than 2 sprays of Rezenopy nasal spray should be administered per day.
- Warnings and precautions associated with Rezenopy include an increased risk of recurrent respiratory and CNS depression, precipitation of severe opioid withdrawal, and an increased risk of adverse cardiovascular effects.
- Common adverse reactions include upper abdominal pain, nasopharyngitis, and dysgeusia.
Development timeline for Rezenopy
| Date | Article |
|---|---|
| Apr 19, 2024 | Approval FDA Approves Rezenopy (naloxone hydrochloride) Nasal Spray for the Emergency Treatment of Opioid Overdose |
Further information
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