FDA approves over-the-counter designation for Narcan nasal spray for the opioid overdose emergency treatment.- Emergent BioSolutions

This decision comes at a time when approximately every eight minutes, a person dies from an opioid overdose and research shows the epidemic is escalating in the U.S. with the rise in synthetic opioids. By offering Narcan nasal spray as an OTC treatment, anyone will be able to access it without a prescription, which is an important step in the fight to reduce the number of opioid overdose deaths occurring each day.

Narcan Nasal Spray was developed for use in the community setting and more than 44 million doses have been distributed since its launch in 2016. This prescription-to-OTC approval is supported by Human Factors study data, an updated Drug Facts label, pharmacovigilance data collected from various public sources, and seven years of post-marketing safety data. The new OTC product will have the same formulation, device design, and original prescription strength (4 mg), which are important features and benefits to help counteract the effects of opioids, including fentanyl, in the community setting.