The decision comes as an attempt to expand access to the life-saving drug as the United States grapples with a wave of overdose deaths.
The United States has decided to make Narcan, a life-saving drug that can reverse drug overdoses, available without a prescription as the country reels from an ongoing crisis. opioid addiction crisis.
In a statement on Wednesday, the U.S. Food and Drug Administration (FDA) announced that naloxone, the generic name for Narcan, would be available over-the-counter in an effort to expand access.
“The agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development and approval of an over-the-counter naloxone product to address the urgent public health need,” the commissioner said. FDA, Robert Califf.
Narcan can quickly stop an overdose and has become a crucial public health tool as the United States struggles to deal with an epidemic of drug-related deaths. In 2021, more than 100,000 people in the United States died from drug overdoses, an increase of 15% over the previous year.
Anyone can save a life during an opioid overdose with naloxone, a life-saving drug that, when sprayed into the nose or injected, quickly reverses the powerful effects of opioids during an overdose. Find out how you could save someone’s life with naloxone. https://t.co/KTGMHSUPS5
— United States FDA (@US_FDA) March 29, 2023
The announcement follows a unanimous recommendation by an independent panel of FDA advisers in February to make Narcan available over the counter.
Emergent BioSolutions Inc, the company that produces Narcan, said it will increase the drug’s availability in pharmacies and online retailers over the coming months. The company’s share price rose nearly 5% following the decision.
Narcan, previously administered as an injection, was approved for use as a nasal spray by the FDA in 2015. Such efforts were made in response to the growing toll drug addiction has taken on American society.
The Centers for Disease Control and Prevention (CDC) marks the start of the opioid epidemic in the 1990s, when opioid painkillers began to be pushed aggressively by pharmaceutical companies And pharmacies.
A second “wave” of opioid-related deaths arrived around 2010, with an increase in heroin-related overdoses.
Today’s addiction crisis is fueled primarily by synthetic opioids fentanylwhich has eclipsed heroin and prescription painkillers as the main source of opioid addiction over the past five years.
Communities across the country have been devastated by the crisis, and authorities have struggled to mount an effective response, as overdose deaths continue to rise.
Easy to use, Narcan has empowered everyday people to help those suffering from overdoses and has been hailed by public health officials as a crucial form of assistance.
“Today’s action paves the way for the lifesaving drug to reverse an opioid overdose that will be sold directly to consumers in places like pharmacies, convenience stores, grocery stores and gas stations, as well as in line,” the FDA said on Twitter. “Anyone can save a life during an opioid overdose.”