Higher Dosage of Naloxone Nasal Spray Approved by FDA to Treat Opioid Overdose

TOPIC: Higher Dosage (8 mg) of Naloxone Nasal Spray Approved by FDA to Treat Opioid Overdose

AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy

ISSUE: On April 30, the U.S. Food and Drug Administration (FDA) announced approval of a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose as part of its efforts to combat the opioid crisis. The FDA granted approval of KLOXXADO to Hikma Pharmaceuticals through the 505(b)(2) approval pathway under the Federal Food, Drug, and Cosmetic Act. The newly approved product delivers 8 milligrams (mg) of naloxone into the nasal cavity, whereas previously approved naloxone nasal spray products delivered 2 mg and 4 mg. A higher dose of naloxone provides an additional option in the treatment of opioid overdoses.

The FDA notes that addressing the opioid crisis is a top priority, specifically efforts to increase access to and the availability of naloxone. Naloxone can counter opioid overdose effects, usually within minutes if administered quickly enough. The use of naloxone in opioid-dependent patients may result in opioid withdrawal symptoms, such as but not limited to body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, restlessness, and increased blood pressure.

BACKGROUND: Naloxone can be administered by individuals with or without medical training and is used to help reduce opioid overdose deaths.

RECOMMENDATIONS: 

• A higher dose of naloxone, as approved by the FDA at 8 mg, provides an additional option in the treatment of opioid overdoses.

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