FDA Approves Narcan Nasal Spray for Opioid Overdose

Two-milligram formulation green-lighted for emergency use

The FDA has given the nod to Narcan nasal spray (naloxone, Adapt Pharmaceuticals) as a 2-mg formulation for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. The 2-mg dose is approved for use in opioid-dependent patients expected to be at risk for severe opioid withdrawal in situations where there is a low risk for accidental or intentional opioid exposure by household contacts.

This approval comes approximately one year after the FDA green-lighted the first ready-to-use, needle-free version of naloxone, Narcan nasal spray 4 mg, which has been commercially available since February 2016 after expedited FDA review and approval.

Narcan nasal spray 2 mg and 4 mg are concentrated naloxone nasal sprays providing ready-to-use emergency treatments for opioid overdose, including overdose related to prescription opioid painkillers, fentanyl, carfentanil, or heroin. The product is not a substitute for emergency medical care.

Source: PR Newswire; January 25, 2017.