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

The first over-the-counter Narcan nasal spray was approved by the U.S. Food and Drug Administration on Wednesday to lessen drug overdose deaths brought on by illegal drugs in the midst of a persistent epidemic that is mostly due to the southern border crisis.

Narcan, a naloxone monohydrate nasal spray, has received national approval for over-the-counter, non-prescription used due to the country’s ongoing pill overdose epidemic. S, citing more than 101,750 individuals who passed away in a 12-month period from overdosing mainly on synthetic drugs like illegal fentanyl.

According to Patrizia Cavazzoni, M. D., director of the FDA’s Center for Drug Evaluation and Research,” Naloxone is a crucial tool in addressing opioid overdoses, and today” s approval underscores the extensive efforts the agency has undertaken to combat the epidemic.

Federal officials, according to Cavazzoni, will collaborate with sponsors looking to advertise for non-prescription naloxone products, including those that require an OTC turn, and they will urge manufacturers to get in touch with the agency right away to start discussions.

The FDA has mandated that Narcan manufacturers alter the naming of common naloxone oral spray products. To get over-the-counter approval, they will be required to submit a product to their applications.

According to the press release from the Centers for Disease Control and Prevention, 107, 735 Americans perished from drug overdoses between August 2021 and november 2022, with 66 % of those fatalities involving synthetic opioids like fentanyl.

Harm reduction organizations have been urging the federal government to find naloxone with federal funds since 2016, according to the Associated Press, and state officials have mandated that trade sell the drug to customers even without prescriptions.

In case of an opioid overdose, authorities from the Los Angeles Unified School District announced last month that individuals may soon bring Narcan nasal spray to school.

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According to a report, 92 % of teenagers who passed away from drug overdoses in Los Angeles County tested positive for fentanyl, with 31 of those deaths being directly related to the lethal opioid.

The Drug Enforcement Administration claimed in December of last year that it had seized enough fentanyl in 2022 to destroy every citizen of the United States. With two days until the year 2022, according to authorities, the DEA had seized about 50.6 million artificial prescription medications laced with fentanyl and more than 10,000 pounds of the drug.

That equates to more than 379 million fatal morphine quantities from the previous year, which would have killed all 333 million Americans.

The Sinaloa and Jalisco Cartels in Mexico, which typically import the chemicals from China, are to blame for the vast majority of fentanyl trafficking into the United States, according to DEA authorities.