Nasal Naloxone On Brink Of OTC Among Additional Opioid Overdose Options On US FDA's Plate
Upcoming goal dates for Emergent’s Narcan and Harm Reduction Therapeutics’ RiVive will test the US FDA’s efforts to nurture the over-the-counter naloxone switch, followed by decisions on higher strength nasal opioid antagonist products from Opiant and Orexo to address fentanyl and other synthetic opioids.
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All members of joint advisory panel noted urgent need to expand access to naloxone and voted yes on OTC sales of Emergent's Narcan nasal spray, but many also pointed out concerns for testing needed for DFl Facts label firm unveiled to the panel as well as to FDA officials during meeting.
Emergent BioSolutions’ announcement of FDA accepting sNDA for an OTC 4-mg naloxone nasal spray marks another recent step in agency’s response under Commissioner Califf to Capitol Hill pressure to expand availability of topioid antagonist to help curb opioid overdose death epidemic.
Harm Reduction Therapeutics submits NDA for OTC approval of a 3-mg naloxone nasal spray branded RiVive. CEO Michael Hufford says the NDA touches all the bases FDA detailed in notice it published on what’s needed in naloxone OTC switch proposals.