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Opioid Crisis Forces Through New FDA Approval

This past Wednesday, the U.S. Food and Drug Administration approved a new over-the-counter Narcan nasal spray, the first of its kind, as a means to drop the rate of drug overdose deaths being pushed by the high level of illicit opioids being found in the wake of an ongoing epidemic largely fueled by the crisis taking place along the nation’s southern border.

Federal officials have issued approval for a naloxone hydrochloride nasal spray, known as Narcan, to be sold over-the-counter, nonprescription use, as the rate of drug overdoses, continues to rise and plague the nation, citing well over 101,750 people that have died in the last year from overdosing mostly on new synthetic opioids such as illegal 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,” explained the director of the FDA’s Center for Drug Evaluation and Research, Patrizia Cavazzoni, M.D., in a recent press release.

The doctor stated that federal officials would be working with a number of sponsors in an effort to heavily market the sale of these nonprescription naloxone products, including via the use of a prescription to OTC switch, along with calling on the manufacturers to make contact with the agency as soon as possible so as to start talks.

As explained by the FDA, the makers of Narcan must alter the labeling for all generic naloxone nasal spray products. They will be forced to send in a supplement to their applications in order to secure over-the-counter approval.

The Centers for Disease Control and Prevention issued a report that 107,735 Americans have died throughout the period of August 2021 and August 2022 due to drug poisonings, with close to 66% of those deaths being afflicted by synthetic opioids like fentanyl, as explained via a news release.

The Associated Press issued a report that harm reduction groups have been calling on the federal government to make use of federal funds to purchase naloxone since 2016, while state officials have ordered pharmacies to sell it to customers, even if they do not maintain a prescription.

This past month, officials with the Los Angeles Unified School District announced students could soon be allowed to carry Narcan nasal spray to class in order to assist with any possible opioid overdoses.

A recent report showed that 92% of teens that died due to a drug overdose in 2021 ended up testing positive for fentanyl in Los Angeles County, with 31 of those being directly related to the fatal opioid.

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