US approves sale of overdose reversal drug without prescription | Drugs News
The decision comes as a bid to widen access to the life-saving drug as the US struggles with a wave of overdose deaths.
The United States has decided to make Narcan, a life-saving medication that can reverse drug overdoses, accessible without a prescription as the country reels from an ongoing opioid addiction crisis.
In a statement on Wednesday, the US Food and Drug Administration (FDA) announced that naloxone, the generic name for Narcan, would be made available over the counter in an effort to widen access.
“The agency has used its regulatory authority to facilitate greater access to naloxone by encouraging the development of and approving an over-the-counter naloxone product to address the dire public health need,” said FDA Commissioner Robert Califf.
Narcan can swiftly halt an overdose and has become a crucial public health tool as the US struggles to address an epidemic of drug-related deaths. In 2021, more than 100,000 people in the US died from drug overdoses, a 15-percent increase 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. Learn how you could save someone’s life with naloxone.
— U.S. FDA (@US_FDA) March 29, 2023
The announcement follows a unanimous recommendation by an independent panel of FDA advisors in February to make Narcan available over the counter.
Emergent BioSolutions Inc, the company that produces Narcan, said that it will step up availability of the drug at pharmacies and online retailers over the next few months. The company’s stock price rose nearly five percent following the decision.
Narcan, previously administered in the form of an injection, was approved for use as a nasal spray by the FDA in 2015. Such efforts have been made in response to the mounting toll that drug addiction has had on US society.
The Centers for Disease Control and Prevention (CDC) marks the beginning of the opioid epidemic in the 1990s, when opioid painkillers started to be aggressively pushed by drug companies and pharmacies.
A second “wave” of opioid deaths arrived around 2010, with a rise in heroin-related overdoses.
Today, the addiction crisis is driven primarily by the synthetic opioid fentanyl, which has eclipsed heroin and prescription painkillers as the main source of opioid addiction over the last five years.
Communities across the country have been devastated by the crisis, and authorities have struggled to mount an effective response, with overdose deaths continuing to climb.
Easy to use, Narcan has allowed everyday people to assist those experiencing an overdose and has been hailed by public health officials as a crucial form of assistance.
“Today’s action paves the way for the life-saving medication to reverse an opioid overdose to be sold directly to consumers in places like drug stores, convenience stores, grocery stores and gas stations, as well as online,” the FDA said over Twitter. “Anyone can save a life during an opioid overdose.”