EBS - Emergent wins FDA nod for first over-the-counter opioid overdose therapy
2023-03-29 10:02:29 ET
- Emergent BioSolutions ( NYSE: EBS ) received FDA approval on Wednesday for Narcan, a nasal spray of opioid overdose therapy naloxone hydrochloride, for over-the-counter (OTC) nonprescription use.
- Narcan 4 milligram is the first FDA-approved naloxone product allowed for use without a prescription, according to the agency.
- The decision comes after an FDA Advisory committee voted unanimously to recommend its approval last month.
- “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country,” FDA Commissioner Robert M. Califf said.
- Drug overdose, mainly driven by synthetic opioids like illegal fentanyl, has led to more than 100,000 deaths in the U.S. over the 12 months ending October 2022.
- Emergent ( EBS ) plans to launch Narcan nasal spray by late summer for OTC use. The company said that the product first launched in 2016 would continue to be available through existing market channels for prescription-only use.
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Emergent wins FDA nod for first over-the-counter opioid overdose therapy