Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Narcan Nasal Spray 2mg

Adapt Pharma news release; 2017 Jan 25

The US Food and Drug Administration (FDA) approved NARCAN Nasal Spray (naloxone HCI) as a 2mg formulation for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

Indications: NARCAN Nasal Spray 2mg is a concentrated naloxone nasal spray providing ready-to-use emergency treatments of opioid overdose, including prescription opioid painkiller-, fentanyl-, carfentanil- and heroin-related overdose. It is not a substitute for emergency medical care.

Dosage/administration: Administer a single spray of NARCAN Nasal Spray to adults or pediatric patients intranasally into 1 nostril. Administer additional doses, using a new nasal spray with each dose. If the patient does not respond or responds and then relapses into respiratory depression, additional doses may be given every 2 to 3 minutes until emergency medical assistance arrives.

Adverse reactions: The following adverse reactions were observed in a NARCAN Nasal Spray clinical study: increased blood pressure, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, and nasal inflammation.


NARCAN (naloxone HCl) Nasal Spray 2mg approved by U.S. Food and Drug Administration (FDA). Adapt Pharma Web site. January 25, 2017. Accessed January 27, 2017.