FDA Approves Rezenopy
FDA Approves Rezenopy (naloxone hydrochloride) Nasal Spray for the Emergency Treatment of Opioid Overdose
April 19, 2024 -- The U.S. Food and Drug Administration has approved Rezenopy (naloxone hydrochloride) nasal spray 10 mg 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.
Drug overdose, including most commonly opioid overdose, is one of the leading causes of accidental death in the United States.
Rezenopy nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present.
Naloxone hydrochloride is an opioid antagonist that works to reverse the effects of opioids during an overdose, including respiratory depression, sedation and hypotension.
Rezenopy is a high dose naloxone hydrochloride nasal spray formulation containing 10 mg of naloxone per spray 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.
Common adverse reactions reported with Rezenopy include upper abdominal pain, nasopharyngitis and dysgeusia.
Rezenopy is manufactured by Summit Biosciences Inc.
Posted: April 2024
Rezenopy (naloxone hydrochloride) FDA Approval History
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