Emergent BioSolutions’ Narcan nasal spray has secured over-the-counter (OTC) designation from the US Food and Drug Administration (FDA), becoming the first and only prescription strength naloxone nasal spray to receive the status in the country.

Narcan Naloxone HCl nasal spray 4 mg is indicated for emergency treatment of opioid overdose, including illegal fentanyl, in the community setting and will now be available without a prescription in the US.

The prescription-to-OTC approval of the FDA was backed by the findings of a Human Factors study, an updated Drug Facts label, pharmacovigilance data collected from various public sources, and seven years of post-marketing safety data.

Emergent BioSolutions, in a statement, said the new OTC product will have the same formulation, device design, and original prescription strength of 4 mg.

Robert G Kramer — Emergent BioSolutions president and CEO said: “Today’s landmark FDA OTC approval for NARCAN Nasal Spray marks a historic milestone as we have delivered on our commitment to make this important emergency treatment widely accessible, given the alarming rates of opioid overdoses occurring across the country.”

“We are dedicated to improving public health and assisting those working hard to end the opioid crisis – so now with leaders across government, retail and advocacy groups, we must work together to continue increasing access and availability, as well as educate the public on the risks of opioid overdoses and the value of being prepared with NARCAN Nasal Spray to help save a life.”

Emergent BioSolutions anticipates the over-the-counter availability of Narcan nasal spray by late summer of this year.

The company said more than 44 million doses of Narcan nasal spray have been distributed since its launch in 2016.

The FDA said more than 101,750 fatal overdoses were reported over the 12-month period ending in October 2022, mainly driven by synthetic opioids like fentanyl.

Narcan nasal spray was first approved by the FDA as a prescription drug in 2015.

  Emergent BioSolutions, naloxone, Narcan Naloxone HCl nasal spray, Robert G Kramer, US FDA, US Food and Drug Administration, USA