The prescription-to-OTC approval is backed by Human Factors study data, an updated Drug Facts label, pharmacovigilance data gathered from multiple public sources, and seven years of post-marketing safety data
Emergent BioSolutions has received approval for its NARCAN Naloxone hydrochloride (HCl) Nasal Spray 4 mg from the US Food and Drug Administration (FDA) as an over-the-counter (OTC) emergency treatment for opioid overdose.
According to the FDA, Naloxone quickly reverses opioid overdose effects and is the standard treatment for overdose of the substance.
NARCAN Nasal Spray is now the first and only prescription strength naloxone nasal spray to receive OTC status in the US.
FDA Commissioner Robert Califf said: “The FDA remains committed to addressing the evolving complexities of the overdose crisis. As part of this work, the agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need.”
The US-based Emergent BioSolutions said that the FDA approval will allow anyone to access the spray without a prescription.
Emergent BioSolutions president and CEO Robert Kramer 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.”
Introduced in 2016 as a prescription drug, the NARCAN Nasal Spray was originally developed for use in the community setting.
The prescription-to-OTC approval is backed by Human Factors study data, an updated Drug Facts label, pharmacovigilance data gathered from various public sources, and seven years of post-marketing safety data.
The new OTC product will have the same device design, formulation and prescription strength (4mg), to help counteract the effects of opioids in the community setting.
Emergent BioSolutions expects the availability of the OTC spray on US shelves and at online retailers by late summer.