USA—The US Food and Drug Administration (FDA) has given the green light for the sale of naloxone, also known as Narcan, a nasal spray used as an emergency treatment to reverse drug overdoses, without a prescription.

The approval, which was announced on 29 March, means that the life-saving medication can now be sold directly to consumers in drug stores, convenience stores, grocery stores, gas stations, and online.

The move is a response to the alarming rates of opioid overdoses occurring across the US.

According to the FDA, in the 12 months leading up to October 2022, more than 101,750 people died of a drug overdose in the country, with synthetic opioids such as illegal fentanyl being the primary cause.

Naloxone spray, sold under the brand name Narcan, has been on the market since 2016, but access was often limited because of its prescription designation.

Emergent BioSolutions, the company that makes Narcan, expects the nasal spray to become available in the US by the late summer after supply chain modifications and new packaging.

“Today’s landmark FDA OTC approval for Narcan nasal spray marks a historic milestone as we have delivered on our commitment to make this important emergency treatment widely accessible,” said Robert G. Kramer, president, and CEO of Emergent BioSolutions.

Narcan was first approved in 2015 as opioid overdose deaths began to increase sharply. After stalling between 2017 and 2019, opioid-related overdose deaths jumped again, rising to over 80,000 in 2021.

The recent approval of Narcan for over-the-counter sale by the FDA is expected to have a positive impact on the number of lives that can be saved in the event of an overdose.

By eliminating the prescription requirement, the nasal spray can be readily available for purchase and kept on hand for emergencies.

The FDA has implemented a comprehensive Overdose Prevention Framework, which includes reducing unnecessary prescriptions for controlled substances, sharing information on the risks of certain drugs, and increasing the availability of evidence-based treatments for substance abuse disorder.

The FDA is also working to protect individuals from counterfeit and unapproved substances as part of the Overdose Prevention Framework

Studies have shown that communities equipped with Narcan have been successful in reducing opioid overdose rates.

For example, a naloxone distribution program in Massachusetts reduced opioid deaths by 11% across 19 communities.

Models also suggest that a high rate of Narcan distribution could prevent 21% of opioid-related deaths.

In Ohio, researchers have shown that placing naloxone vending machines outside syringe service programs (SSP) has saved thousands of lives.

In its first year of use, the machine dispensed 3360 naloxone doses, more than any other SSP in the US.

Communities across the US are grappling with the devastating impact of opioid addiction and overdose.

The University of Pittsburgh’s community-based approach has been particularly successful in reducing the rate of overdose deaths.

The Pennsylvania Opioid Overdose Reduction Technical Assistance Center uses community leaders to plan and organize efforts fighting opioid addiction and overdose in their jurisdictions.

According to PatientEngagementHIT, this approach has reduced opioid overdose deaths across nearly 66% of the counties involved.

Major corporations stepped up to pay for opioid crisis in 2022

Drug policy experts are in agreement that the opioid crisis in the US was ignited by the aggressive marketing and selling of opioids by Big Pharma.

Despite the overwhelming evidence pointing to the culpability of corporations, it wasn’t until 2022 that some of America’s largest companies, including AmerisourceBergen, Cardinal Health, CVS, Johnson & Johnson, and Walmart, came to the negotiating table to strike deals.

While admitting no wrongdoing, these corporations agreed to pay more than US$50 billion dollars in settlements.

While this amount represents only a fraction of the public cost of the opioid crisis, the settlement money could prove to be a game-changer.

Most of the opioid money has been lock-boxed by court agreements in a manner that ensures it will be directed towards funding addiction treatment and healthcare over the next two decades.

In conjunction with the significant increases in state and federal funding for addiction care over the past year, corporate cash could make addiction treatment far more accessible and affordable, particularly for people in impoverished rural areas and urban neighborhoods.

Corporations still under DOJ scrutiny

Looking ahead to 2023, the U.S. Department of Justice continues to scrutinize the corporations involved in the opioid business.

Although most of these corporations have reached settlements with state and local governments, they still face legal action from the DOJ.

The department has already sued two of the country’s top-10 largest corporations over opioids – AmerisourceBergen and Walmart – and more civil complaints against other companies are expected to follow.

Nevertheless, the corporations insist that they did not act wrongly, and billions of dollars in fines and penalties are at stake.

In recent years, the Sackler family, which owns Purdue Pharma, has emerged as the public face of the opioid crisis.

While they admit to no personal wrongdoing, their company has pleaded guilty twice to federal crimes related to opioid marketing, first in 2007 and again in 2020.

Purdue Pharma’s flagship product, Oxycontin, became one of the most widely abused pain pills, leading to countless addiction cases and overdose deaths.

In March 2022, the Sackler family, who were the owners of Purdue Pharma, reached a significant settlement with state attorneys general.

Under review by the federal courts, the US$6 billion deal has raised questions regarding potential immunity from future opioid lawsuits for members of the Sackler family.

However, if finalized, the settlement money would go toward funding drug treatment programs across the United States.

In addition to the settlement, the victims had a confrontation with the members of Sackler’s family for the first time during an emotional court proceeding held over videoconference.

As part of the settlement process, survivors of addiction and those who lost family members due to opioid overdoses addressed the Sacklers directly. They described the suffering and agony caused after Oxycontin flooded communities.

While the settlement is under review, the U.S. Court of Appeals for the 2nd Circuit in Manhattan is expected to make a ruling in 2023.

It is worth noting that the potential immunity granted to the Sackler family is a controversial topic, and critics argue that it is unfair to victims and that the Sacklers should be held accountable for their role in the opioid crisis.

If the deal is approved, the US$6 billion settlement would provide significant financial support to drug treatment programs, offering a glimmer of hope for those affected by addiction across the United States.

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