Over-the-Counter Narcan to Reverse Overdoses May Be Available Early Next Year

An over-the-counter nasal spray meant to stop deadly opioid overdoses might attain cabinets early subsequent yr. The Food and Drug Administration has reportedly fast-tracked the approval technique of an OTC naloxone spray from Emergent BioSolutions, the builders of Narcan. The FDA is anticipated to decide on its approval by late March 2023.

Naloxone is an opioid antagonist, which means it prevents different opioids from activating the opioid receptors in our cells. It can shortly reverse the signs of a probably deadly overdose, such because the lack of respiration. Naloxone may be deployed as an injection or a nasal spray, with Emergent’s Narcan being the one FDA-approved nasal naloxone spray till earlier this yr, when two generics launched.

In latest months, hurt discount advocates have been capable of increase the availability of available injectable naloxone following longstanding shortages. But specialists have lengthy argued that making it doable for naloxone to be offered over-the-counter would assist curb the rising variety of opioid overdose deaths (over 100,000 Americans died from an overdose in 2021). The FDA has been reluctant to contemplate approving OTC variations of injectable naloxone, but it surely has signaled that it wouldn’t flip down OTC variations of the auto-injectable and nasal spray merchandise. Last month, the FDA even formally sent out a notice calling for firms to submit their purposes. And Emergent has seemingly heeded the decision.

The firm introduced early Tuesday that the FDA has agreed to conduct a precedence assessment of its software for a 4 milligram OTC model of Narcan—purportedly the primary such assessment for any product switching from prescription to OTC. Priority evaluations pace up the standard timeline for the FDA to judge a possible approval, often to inside six months of the applying being submitted. According to Emergent, the company’s deadline to resolve 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,” stated Robert G. Kramer, president and CEO of Emergent, in a statement from the corporate. “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 a part of its software to the FDA, Emergent has submitted 5 years of post-marketing knowledge on Narcan. Though these merchandise are technically prescription-only, authorities initiatives and hurt discount applications lately have made it doable for many individuals to acquire naloxone to make use of in emergencies, with out the express want for a health care provider’s prescription. And in its November discover, the FDA said that OTC nasal naloxone sprays have the “potential to be safe and effective for use” with out medical supervision.

The FDA will nonetheless must concern the ultimate phrase on approval, nonetheless. And if even an OTC Narcan spray does develop into actuality, its worth is more likely to be an essential consider whether or not it really makes naloxone extra extensively accessible. A single Narcan equipment at present can cost anywhere from $22 to $60, which is rather more costly than the most affordable accessible injectable model. At least one different firm is reportedly planning to submit its personal software for a OTC naloxone product, delivered through nasal swab, as effectively.