Upcoming OTC Naloxone Joint Advisory Committee Meeting Cancelled

As of the morning of March 1, the hotly anticipated Joint Meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee originally scheduled for March 20 has been cancelled.  The March 20 Joint Meeting concerned the NDA for naloxone hydrochloride nasal spray for nonprescription use as an opioid reversal agent in the emergency treatment of opioid overdose which was submitted by Harm Reduction Therapeutics under the trade name RiVive.  RiVive would be a direct-to-OTC approval and would represent a potential first in class product in a new therapeutic category for nonprescription drugs.  The issues for discussion at the March 20 Joint Meeting were intended to cover the adequacy of the data supporting the nonprescription application for the product.  The reason for the cancellation—scheduled to be published in the Federal Register on March 2—is that “the meeting is no longer needed.”  No further information concerning the cancellation has been made available at this time.

We previously blogged on the February 15, 2023 Joint Meeting of the same advisory committees concerning the rx-to-OTC switch application for Narcan Nasal Spray (NNS).  All 19 members of the joint Advisory Committee agreed that the benefit-risk profile of NNS is “supportive of its use as a nonprescription opioid overdose reversal agent.”  FDA has not yet taken action on the NNS application, but the Prescription Drug User Fee Act (PDUFA) goal date by which a decision is expected is March 29, 2023.