The decision comes as an effort to broaden access to the life-saving drug as the US grapples with a spate of overdose deaths.
The United States has decided to make Narcan, a lifesaving drug that can reverse drug overdose, accessible without a prescription as the country reels from an ongoing 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 become available over the counter in an effort to broaden 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 meet the urgent public health need,” said FDA- Commissioner Robert Califf.
Narcan can quickly halt overdose and has become a critical public health tool as the US struggles to deal with an epidemic of drug-related deaths. In 2021, more than 100,000 people in the US died of drug overdoses, a 15 percent increase from the previous year.
Anyone can save a life during an opioid overdose with naloxone, a life-saving drug that, when sprayed or injected into the nose, quickly reverses the powerful effects of opioids during an overdose. Find out how you can save someone’s life with naloxone. https://t.co/KTGMHSUPS5
— US FDA (@US_FDA) March 29, 2023
The announcement follows a unanimous recommendation from an independent panel of FDA advisers in February to make Narcan available over the counter.
Emergent BioSolutions Inc, the company that manufactures Narcan, said it will ramp up availability of the drug at pharmacies and online retailers in the coming months. The company’s share price rose nearly five percent after the decision.
Narcan, previously given in the form of an injection, was approved by the FDA in 2015 for use as a nasal spray. Such efforts have been made in response to the increasing toll that drug addiction has taken on American society.
The Centers for Disease Control and Prevention (CDC) marks the beginning of the opioid epidemic in the 1990s, when opioid painkillers were aggressively pushed by drug companies and pharmacies.
Around 2010 came a second “wave” of opioid deaths, with an increase in heroin-related overdoses.
Today, the addiction crisis is primarily driven by the synthetic opioid fentanyl, which has eclipsed heroin and prescription painkillers as the leading source of opioid addiction in the past five years.
Communities across the country have been devastated by the crisis and authorities are struggling to respond effectively, with overdose deaths continuing to rise.
Narcan is easy to use and has enabled ordinary people to help those experiencing drug overdoses and has been praised by public health officials as a critical form of assistance.
“Today’s action paves the way for the life-saving medication to reverse opioid overdose, which is sold directly to consumers in places such as drugstores, convenience stores, supermarkets and gas stations, as well as online,” the FDA said via Twitter. . “Anyone can save a life during an opioid overdose.”