Emergent BioSolutions (NYSE:EBS) announced today that its over-the-counter Narcan (naloxone HCl) nasal spray received unanimous approval from governing bodies.
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.
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