Emergent BioSolutions (NYSE: EBS) announced today that governing bodies unanimously approved its over-the-counter Narcan (naloxone HCl) nasal spray. The FDA Non-prescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee cast their votes.
A total of 19 people voted in favor of Narcan’s benefit-risk profile. Voters support its use as a non-prescription opioid overdose reversal agent.
Based in Gaithersburg, Maryland, Emergent discussed its over-the-counter (OTC) development program. It also included data on medical needs, human factors research, and seven years post-marketing safety data. The committee’s recommendations do not bind the FDA, but the agency will consider them.
Since receiving FDA approval in 2015, the company has distributed millions of prescription Narcan devices in the United States. This includes distribution to national, state, and local health departments and first responders.
In December, the FDA approved Emergent’s supplemental new drug application (sNDA) for the Narcan opioid overdose emergency treatment. It also gave the application priority consideration.
It would be the first 4 mg naloxone nasal spray available over the counter in the United States. According to Emergent, the Prescription Drug User Fee Act’s target date is March 29, 2023.
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