WASHINGTON, D.C. — The life-saving overdose reversal drug Narcan may soon be available over the counter.
According to a press release from the manufacturer, Emergent BioSolutions, the federal Food and Drug Administration (FDA) has accepted for review its supplemental new drug application as an over-the-counter (OTC) emergency treatment for known or suspected opioid overdose.
The company says “the application has been granted Priority Review by the FDA and, if approved, would be the first 4 mg naloxone nasal spray available OTC in the U.S.”
The Centers for Disease Control and Prevention said deaths related to synthetic opioids increased by nearly 60 percent from 2019 to 2020. In 2021 nearly 100,000 people died nationwide from opioids containing fentanyl.
“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 BioSolutions. “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.”