The vote came from the FDA Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. A total of 19 voters decided in favor of the benefit-risk profile for Narcan. The voters support its use as a nonprescription opioid overdose reversal agent.
Gaithersburg, Maryland-based Emergent presented an overview of its over-the-counter (OTC) development program. It also presented the medical need, human factors study data and seven years of post-marketing safety data. The committees’ guidance does not bind the FDA but the agency will take its advice into consideration.
The company distributed millions of prescription Narcan devices in the U.S. since garnering approval in 2015. That includes distribution to national, state and local government health departments plus first responders.
The FDA accepted Emergent’s supplemental new drug application (sNDA) for the Narcan opioid overdose emergency treatment in December. It also granted the application priority review. If approved, it would mark the first 4 mg naloxone nasal spray available OTC in the U.S. Emergent said the Prescription Drug User Fee Act goal date falls on March 29, 2023.
“This favorable recommendation marks another important step forward to broaden access to NARCAN Nasal Spray for those who may be at risk of an opioid overdose,” said Paul Williams, SVP and products business head, Emergent BioSolutions. “Today’s vote reaffirms our confidence in the safe and effective use of NARCAN in the community setting. We want to thank the participants in the open public hearing who shared their insights and personal experiences informing the need to make NARCAN more readily available over the counter.”
