Naloxone Access Update: Over-the-counter Narcan expected in March, 2023

Narcan nasal spray in the package.

Emergent BioSolutions Inc. has announced that the FDA has fast-tracked their application for an over-the-counter (OTC) version of their trademarked Narcan nasal spray, and are anticipating approval as early as March 29th, 2023.

A week prior, FDA Commissioner Robert Califf issued an open call for such applications, promising to assign them top priority, requiring that sufficient data be provided to evince efficacy and safety of the OTC product, as well as clinically meaningful differences from existing prescription products. As it pertains to naloxone nasal spray, the FDA does not require that the formulation be altered, merely that people using the product be able to understand the instructions and administer the medication without the assistance or instruction of a healthcare provider.

It is already legal to acquire naloxone without a prescription. As of 2016, Tennessee pharmacists have been permitted to dispense naloxone to any person at risk of an overdose, or to any family member, friend or close associate of such an individual.  Despite this, some pharmacies might require additional verification or stipulations (such as requiring a referral from a clinician or a health department). Should naloxone be made available OTC, a person seeking naloxone would experience fewer barriers.

Cost of the drug could remain a significant barrier, however.  Per GoodRx, Narcan is currently marketed with an average retail price of $143 per box, each of which contains two units. Generic naloxone nasal spray has an average retail price of about $90 per box. Robert Kramer, president and CEO of Emergent BioSolutions, has stated that they have not yet determined the price of the OTC naloxone product.  Other companies have announced plans for OTC naloxone products of their own, with the intention of making them “cheap and widely available.”

If such products were indeed inexpensive and widely available, this would lead to a significant improvement in naloxone access.

Importantly, this could negatively impact supply. In 2020, production delays significantly impaired the supply of injectable naloxone, which remains the least expensive version of the drug. Furthermore, considering how several states have piloted naloxone vending machines and seen their supplies exhausted on the first day, it is reasonable to assume that pharmacies stocking OTC naloxone will face significant pressure to keep their stores supplied.