This second shelf-life extension for the OTC naloxone hydrochloride 4 mg spray continues the FDA's campaign to prevent drug overdose and related fatalities.
The US Food and Drug Administration (FDA) on Wednesday announced that the shelf-life of newly manufactured lots of naloxone hydrochloride 4 mg nasal spray (Narcan) is extended from 3 years to 4 years. The step, initiated by manufacturer Emergent BioSolutions at FDA’s request, is the most recent action taken as part of the agency’s effort to prevent overdoses and to reduce overdose-related mortality through expanded access to naloxone and similar agents formulated to reverse opioid overdose.1
Naloxone, an opioid antagonist, rapidly blocks and reverses the effects of opioids including fentanyl, heroin, morphine, and oxycodone. It is not a controlled substance although its original approval in 2015 was as a prescription drug. In March 2023, the FDA approved naloxone 4 mg nasal spray as the first naloxone product for over the counter, nonprescription use.
“Naloxone is an important tool in addressing opioid overdoses,” stated Marta Sokolowska, PhD, deputy center director for Substance Use and Behavioral Health in FDA’s Center for Drug Evaluation and Research. “Today’s shelf-life extension of newly manufactured lots of Narcan 4 mg nasal spray supports the FDA’s Overdose Prevention Framework and efforts to ensure more OTC naloxone products remain available to the public.”1
The FDA requested and approved a previous shelf-life extension for the Emergent BioSolutions product from 2 years to 3 years in August 2020, the agency said. The current extension applies only to naloxone nasal spray 4 mg produced and distributed by the company after January 17, 2024; for products produced and distributed before this announcement, the shelf-life is not affected. In its statement the agency advised prescribers, patients, and caregivers to follow expiration dates as currently printed on product packages and within labeling.
Fatal drug overdoses continue to plague the US; according to the Centers for Disease Control and Prevention, the overdose death rate surpassed 112 000 in a 12-month period for the first time, driven primarily by wide availability synthetic opioids like illicit fentanyl. FDA’s 2023 OTC approval made the nasal spray available directly to consumers at easily accessible locations such as grocery stores, gas stations, and online.
The FDA’s decision to change the status of naloxone nasal spray from prescription to nonprescription was based on data provided by the manufacturer that demonstrated that the drug is safe and effective for use as directed in its proposed labeling. Also, the agency said that the manufacturer showed that consumers can understand how to use naloxone safely and effectively without the supervision of a health care professional.