25 January 2017 - Adapt Pharma to provide 2 mg as an additional dosing option for naloxone nasal spray
January 25, 2017 – Today, the U.S. FDA approved Narcan nasal spray 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 just over one year after the FDA approved the first-of-its-kind, ready-to-use, needle-free version of naloxone, Narcan nasal spray 4mg, which has been commercially available since February 2016 following expedited FDA review and approval.