FDA Panel to Review Over-the-Counter Approval for Emergent BioSolutions' Narcan Nasal Spray

Key Insights

• FDA advisors are set to evaluate Emergent BioSolutions' Narcan nasal spray for potential over-the-counter (OTC) use, aiming to broaden access to this crucial opioid overdose antidote.
• Emergent BioSolutions will present data to a joint FDA advisory committee, demonstrating Narcan's safe and effective use without medical supervision.
• The FDA's decision, expected by March 29, could significantly impact the availability of naloxone amid the ongoing opioid crisis, pending the advisory panel's recommendation.

US health advisors are preparing to consider whether Emergent BioSolutions Inc.’s opioid overdose reversal drug is safe to sell without a prescription, a move hoped to raise access amid a surging death toll for the decades-long public-health crisis.

Emergent will present findings to a joint meeting of two US Food and Drug Administration advisory panels Wednesday aimed at showing its nasal spray, sold under the brand name Narcan , can be used without oversight from a medical professional. Advice from the outside groups — the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee — isn’t binding, but the FDA frequently adopts their recommendations and has said it intends to return a decision by March 29.