FDA approves extended shelf-life for NARCAN nasal spray


Emergent BioSolutions Inc. announced Monday that the U. S. Food and Drug Administration (FDA) had approved the extended shelf-life of NARCAN nasal spray, used to help reverse the life-threatening effects of an opioid overdose, from 24 months to 36 months.

NARCAN nasal spray is the first intranasal form of naloxone approved by the FDA as an emergency treatment of a known or suspected opioid overdose. Known as an opioid antagonist, it is used for complete or partial reversal of the effects of opioid overdose, including respiratory depression.

“Emergent is pleased to receive FDA approval of the shelf life extension for NARCAN Nasal Spray,” said Doug White, senior vice president and devices business unit head at Emergent. “This is an example of our continued efforts to innovate and improve product features designed to address the needs of patients, consumers, health care providers, pharmacists, and first responders.”

In early July, Emergent launched the Generation II NARCAN Nasal Spray device, which enhanced temperature excursions and storage below 25 degrees Celsius.

NARCAN nasal spray does not require assembly or any specialized medical training, the company said, and is also the highest concentrated dose of intranasal naloxone currently available. The company said patients should tell their healthcare provider if they have any medical conditions before using NARCAN nasal spray, such as if they have heart problems, are pregnant or intend to become pregnant, or if they are breastfeeding.

In order to help combat the national opioid crisis, states and municipalities have moved to make NARCAN nasal spray available to first responders and law enforcement officers. In recent years, the move has been to ensure that NARCAN is available to the friends and family of opioid users in case of accidental overdose. In June, a report from CME Outfitters, a continuing medical education organization, suggested that co-prescribing of naloxone in any form could not only be a life-saving measure for those with opioid use disorder, but also be a path forward for prescribers to talk to patients about the risk of accidental overdose.