FDA Approves First Over-The-Counter Narcan Nasal Spray Amid Ongoing Opioid Crisis

 The U.S. Food and Drug Administration on Wednesday approved the first over-the-counter Narcan nasal spray to reduce drug overdose deaths driven by illicit opioids amid an ongoing epidemic largely fueled by the southern border crisis.

Federal officials approved Narcan, a naloxone hydrochloride nasal spray for over-the-counter, nonprescription use, as drug overdoses continue to plague the U.S, citing more than 101,750 people who died in a 12-month time frame from overdosing primarily on synthetic opioids like illicit fentanyl.

“Naloxone is a critical tool in addressing opioid overdoses and today’s approval underscores the extensive efforts the agency has undertaken to combat the overdose crisis,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a news release.

Cavazzoni said that federal officials would work with sponsors seeking to market such nonprescription naloxone products, including through a [prescription] to OTC switch, and encourage manufacturers to contact the agency as early as possible to initiate discussions.

According to the FDA, manufacturers of Narcan must change the labeling for generic naloxone nasal spray products. They will be required to submit a supplement to their applications to receive over-the-counter approval.

The Centers for Disease Control and Prevention reported 107,735 Americans died between August 2021 and August 2022 from drug poisonings, with 66% of those deaths involving synthetic opioids like fentanyl, according to the news release.

The Associated Press reported harm reduction groups have been urging the federal government to use federal funds to buy naloxone since 2016, while state officials have ordered pharmacies to sell it to customers, even without prescriptions.

Last month, Los Angeles Unified School District officials announced students could soon carry Narcan nasal spray at school in case of an opioid overdose.

A report showed 92% of teens who died from drug overdoses in 2021 tested positive for fentanyl in Los Angeles County, with 31 directly related to the deadly opioid.

The Drug Enforcement Administration said last December that the agency seized enough fentanyl in 2022 to kill every American citizen. Officials said the DEA had confiscated some 50.6 million fake prescription pills laced with fentanyl and more than 10,000 pounds of fentanyl powder with two weeks left in the calendar year 2022.

That amounts to more than 379 million lethal doses of fentanyl last year, more than enough to kill all 333 million people in the United States.

DEA authorities blamed the vast majority of fentanyl trafficked into the United States on the Sinaloa Cartel and Jalisco Cartel in Mexico, which primarily source the chemicals from China.