FDA Advisory Committee Recommends Making Narcan, Opioid Antidote, Available Over-the-Counter

A panel of scientific experts is recommending the FDA make the opioid overdose antidote Narcan available over-the-counter without a prescription, allowing consumers to obtain the critical nasal spray in places like gas stations and grocery stores, to help combat the death toll from the ongoing opioid epidemic.

In a unanimous vote Wednesday, the FDA’s Joint Nonprescription Drug Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee indicated that consumers should be able to obtain the opioid reversal medication without going to a doctor to obtain a prescription, which would greatly increase access to the product and potentially save thousands of lives.

Narcan (naloxone) is sold as a 4-milligram dose nasal spray, which is approved to reverse the effects of an opioid overdose and in many cases, prevents fatal overdoses from occurring prescription painkillers like Oxycodone, as well as illicit opioids like heroin and fentanyl.

Opioids are responsible for 70% of drug overdose deaths in the U.S., and the nasal spray has been heralded as an important part of the nationwide effort to address the opioid addiction and abuse problems that have plagued communities nationwide in recent years.

Currently, Narcan is only available through a pharmacy, but the FDA advisory committee vote may prompt the agency to allow over-the-counter sales of the opioid reversal medication.

As early as 2014, a World Health Organization report the availability of Narcan over the counter could prevent tens of thousands of overdoses every year. In November, the FDA asked drug companies that make naloxone to apply for over-the-counter approval for the medication.

While the FDA is not required to follow the advisory committee’s advice, the fact that the FDA was already asking companies to apply for OTC approval, and the unanimous vote by the committee, suggests it is likely the FDA will follow its recommendations.

Opioid Overdose Risks

Largely spurred by inappropriate prescribing by doctors, the opioid epidemic has continued to worsen in the United States, reaching an all-time high and accelerated by problems related to the COVID-19 pandemic. Health experts say the decision to allow over-the-counter sales of Narcan may save thousands of lives.

The risk of overdose is now too great to prevent the drug from being availing over-the-counter, warned the committee. Drug overdoses are the leading cause of accidental death in the U.S. The number of naloxone prescriptions increased from 359,000 in 2017 to 1.5 million in 2021.

The committee determined Narcan medication is safe to use without medical supervision. When given to someone who is not having an opioid overdose, the drug has no effect.

It is easily administered by placing it into the nose of someone suffering an overdose and spraying it into their nasal passage. Additional doses can be administered two to three minutes after the first dose without any side effects.

Not all pharmacies keep the drug in stock to be filled via prescription. The new move would allow the opioid-reversal drug to be widely available at pharmacies, convenience stores grocery stores, and even vending machines.

The recommendation will go to the FDA and the agency will give a final decision on March 29.