FDA Approves Additional Dosing for Naloxone Nasal Spray

Officials with Adapt Pharma announced the FDA approval of Narcan (naloxone HCI) Nasal Spray additional dosing. The naloxone nasal spray will be available as a 2-mg formulation indicated for the emergency treatment of opioid overdose, as manifested by respiratory and/or central nervous system depression.

The FDA’s approval comes just 1 year after the 4-mg Narcan Nasal Spray was approved as the first of its kind, needle-free version of naloxone. Both formulations are ready-to-use concentrated naloxone nasal sprays intended for immediate administration as emergency treatment of opioid overdose.

The 2-mg formulation 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.

Reference

NARCAN (naloxone HCI) Nasal Spray 2 mg Approved by US Food and Drug Administration (FDA) [news release]. Dublin. Adapt Pharma’s website. http://adaptpharma.com/adapt_press_release/january-25-2017-narcan-nasal-spray-2mg-approved-by-us-food-and-drug-administration/. Accessed Jan 25, 2017.