Last month, the FDA showed it may be ready to play ball on approving nonprescription naloxone. Now, one of the overdose reversal drug’s flagship brands—Emergent BioSolutions’ nasal spray Narcan—is positioning itself for a swift pivot from regulators’ desks to the pharmacy counter.
Tuesday, Emergent said the FDA had accepted a supplemental drug application to potentially approve Narcan 4mg spray as an over-the-counter (OTC) product. The regulator blessed Emergent’s filing with a priority review, setting an action date of March 29, 2023.
Emergent’s bid is the first switch from prescription to an over-the-counter application to receive the speedy review tag, the company pointed out in a release. If approved, the company’s product would become the first naloxone product available without a doctor’s note in the U.S.
As it stands, current naloxone products require a prescription, though all 50 states in the U.S. have access laws allowing pharmacists to dispense the drug without physician sign-off.
But despite those laws, access barriers persist, the FDA said last month. It flagged “knowledge gaps” around state-level naloxone access that could be keeping certain pharmacies from dispensing the med. The comments were tucked into a federal register notice issued in late November, in which the regulator released its preliminary assessment that certain naloxone products “may be approvable” for over-the-counter use.
The agency tethered its OTC endorsement to naloxone nasal spray and intramuscular autoinjector delivery formats, singling out Narcan and also Kaleo’s prefilled injector Evzio as prime candidates for the potential prescription shift.
While injectable naloxone is the cheapest form of the medicine, its vial and syringe format “poses particular challenges for OTC development,” since those products would need to be usable by members of the public who may have never injected a medication, the FDA’s Patrizia Cavazzoni, M.D., said at a naloxone access workshop in March.
While the FDA’s federal register notice is relatively new, Emergent has been working with the regulator on an over-the-counter switch for its overdose reversal drug for “quite some time,” an Emergent spokesperson explained over email.
“We submitted our official application in late September and have continued and will continue working closely with the FDA to gain approval,” he added.
Emergent says its latest supplemental filing cites human factors studies, plus more than five years of post-marketing data that suggest Narcan is safe and effective. When the drug was approved in 2015, it became the first intranasal formulation of naloxone.
The manufacturer notes accidental overdoses can happen “to anyone, anywhere, at any time.” OTC status would increase Narcan access, Emergent figures, in turn dialing up the heat on the opioid epidemic in the U.S.