FDA Quickly Approves Narcan Nasal Spray
Last month, in a very quick timeframe, the Food and Drug Administration (FDA) approved Narcan, the nasal spray form of naloxone, the medication that “can stop or reverse the effects of an opioid overdose” (Lavitt, 2015).
In response to the ever-growing opioid epidemic in the US, the FDA allowed the “fast-track designation and priority review” for the Narcan nasal spray. The approval process for this drug took less than four months, despite its target date of January 2016.
According to FDA Acting Commissioner Stephen Ostroff, MD, “Combating the opioid abuse epidemic is a top priority for the FDA. We cannot stand by while Americans are dying. While naloxone will not solve the underlying problems of opioid epidemic, we are speeding to review new formulations that will ultimately save lives that might otherwise be lost to drug addiction and overdose” (Lavitt, 2015).
Up until this recent approval, only the injectable naloxone was federally approved.
Lavitt, J. (2015). FDA fast tracks approval of Narcan nasal spray to fight opioid epidemic. Retrieved from https://www.thefix.com/fda-fast-tracks-approval-narcan-nasal-spray-fight-opioid-epidemic