An over-the-counter nasal spray meant to prevent fatal opioid overdoses could reach shelves early next year. The Food and Drug Administration has reportedly fast-tracked the approval process of an OTC naloxone spray from Emergent BioSolutions, the developers of Narcan. The FDA is expected to make a decision on its approval by late March 2023.
Naloxone is an opioid antagonist, meaning it prevents other opioids from activating the opioid receptors in our cells. It can quickly reverse the symptoms of a potentially fatal overdose, such as the loss of breathing. Naloxone can be deployed as an injection or a nasal spray, with Emergent’s Narcan being the only FDA-approved nasal naloxone spray until earlier this year, when two generics launched.
In recent months, harm reduction advocates have been able to increase the supply of readily available injectable naloxone following longstanding shortages. But experts have long argued that making it possible for naloxone to be sold over-the-counter would help curb the growing number of opioid overdose deaths (over 100,000 Americans died from an overdose in 2021). The FDA has been reluctant to consider approving OTC versions of injectable naloxone, but it has signaled that it wouldn’t turn down OTC versions of the auto-injectable and nasal spray products. Last month, the FDA even formally sent out a notice calling for companies to submit their applications. And Emergent has seemingly heeded the call.
The company announced early Tuesday that the FDA has agreed to conduct a priority review of its application for a 4 milligram OTC version of Narcan—purportedly the first such review for any product switching from prescription to OTC. Priority reviews speed up the typical timeline for the FDA to evaluate a potential approval, usually to within six months of the application being submitted. According to Emergent, the agency’s deadline to decide on the approval of its OTC spray is March 29, 2023.
“As a leader in the fight to help combat the opioid epidemic, Emergent is committed to increasing access and awareness of naloxone, and we are taking this step to help address the rising and devastating number of opioid overdoses and fatalities happening across the country,” said Robert G. Kramer, president and CEO of Emergent, in a statement from the company. “We look forward to working with the FDA to advance our application under Priority Review designation and believe in the scientific evidence that supports the efficacy and safety of NARCAN Nasal Spray as an over-the-counter option for opioid overdose reversal.”
As part of its application to the FDA, Emergent has submitted five years of post-marketing data on Narcan. Though these products are technically prescription-only, government initiatives and harm reduction programs in recent years have made it possible for many people to obtain naloxone to use in emergencies, without the explicit need for a doctor’s prescription. And in its November notice, the FDA stated that OTC nasal naloxone sprays have the “potential to be safe and effective for use” without medical supervision.
The FDA will still have to issue the final word on approval, however. And if even an OTC Narcan spray does become reality, its price is likely to be an important factor in whether it truly makes naloxone more widely accessible. A single Narcan kit today can cost anywhere from $22 to $60, which is much more expensive than the cheapest available injectable version. At least one other company is reportedly planning to submit its own application for a OTC naloxone product, delivered via nasal swab, as well.