Over the counter Narcan opioid overdose antidote a possibility: FDA

Overdose antidote Narcan is moving one step closer to being available to the general public — without a prescription.

US Food and Drug Administration reps are meeting with advisers Wednesday to discuss a proposal to sell an over-the-counter version of the lifesaving drug.

Naloxone spray — often used to reverse the effects of fentanyl overdose — is available with a prescription, but health professionals argue if the antidote is more readily available it would save many more lives as with opioid epidemic continues.

In 2021, the Centers for Disease Control and Prevention reported 107,622 drug overdose deaths. By 2022, the CDC found 110,236 people died within a 12-month period from a drug overdose — marking a alarming new record. The spike in fatalities has been linked to the spread of fentanyl, with the Drug Enforcement Administration announcing in December 2022 that US Border Patrol agents seized “enough to kill every American five times over.”

However, fentanyl is increasingly killing people who don’t even know they’re ingesting it, as it’s often cut into what look like prescription pills and sold as “Oxytocin” or “Xanax” — but actually lead to overdoses and death. The alarming statistics have led the Biden administration to push making Narcan more accessible by “providing naloxone, decreasing stigma, increasing linkage to care, and improving bystander education and response.”

Narcan’s manufacturer, Emergent BioSolutions Inc., proposed the new change in accessibility, with this week’s meeting being held between FDA’s Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee.

In December, FDA Commissioner Robert Califf said naloxone products — which work by displacing the opioid molecules that bind to the brain’s opioid receptors, reversing the life-threatening effects of an overdose — should be as available to the public as defibrillators.

“Any application we get, this is a high priority,” Califf said. “They will get looked at as quickly as we can.”

Naloxone has been available in injectable kits since the ’70s, but in 2015, Narcan’s all-in-one nasal spray was approved on a prescription-only basis by the FDA, making it much easier for the average citizen to administer the treatment with only minimal training.

There’s no limit to how many times one can take it, Dr. Hillary Kunins, Assistant Commissioner for the Bureau of Alcohol and Drug Use for the NYC Department of Health and Mental Hygiene, previously told The Post. However, although it’s safe to use even if the patient is not on opioids, it may cause symptoms of withdrawal in those who have developed an addiction.

“Our main objective is to get naloxone kits into the hands of people … who will be in the position to respond,” Kunins said.

The FDA first approved naloxone spray in 1971 but it was only available to hospitals and emergency services.

The antidote is also available in an injection, but in briefing documents Emergent argued the spray is easier to distribute and administer, as it’s designed for people who have not received medical training.

At the moment, Narcan is available to patients and caregivers from a pharmacy without a prescription, but experts believe the stigma surrounding the drug may prevent people from obtaining it.

The hope is by making the nasal spray available to over the counter, it may remove the stigma and facilitate the use of it for emergency situations.

In its 2022 application to switch to over-the-counter status, Emergent didn’t alter the formulation of Narcan, Wall Street Journal reported. The FDA asked only that Emergent test whether those using the antidote could understand instructions on the packaging and administer the drug without the aid of a prescriber. 

All 50 states, the District of Columbia and Puerto Rico have laws that allow naloxone to be sold without a prescription at a pharmacy — but it still must be bought from a pharmacist.

Pharmaceutical studies suggest more people would use naloxone products if they were available over-the-counter, “for a variety of reasons, including negative personal experiences and fear of provider stigma.”

Robert Kramer, president and chief executive of Emergent, previously said the company hasn’t determined what the price would be for the over-the-counter drug. The average price of a two-pack of prescription-only Narcan nasal sprays is currently $44.64, according to GoodRx.

The Department of Health and Mental Hygiene of NYC’s web page and the free NARCAN: Behind Every Bar Campaign provide information on how to recognize and respond to overdose, where to find naloxone, how to use it, plus guidance on recovery and drug prevention. If you experience issues trying to obtain naloxone at one of the participating pharmacies, contact 311 to report the incident and call 1-888-NYC-WELL to be referred to another provider.