FDA Considers Forgoing Prescription For Narcan

FDA Will Hear Case For Allowing Narcan Over-The-Counter

Advisors to the United States Food and Drug Administration (FDA) met on Wednesday, February 15, to discuss whether a nasal spray version of the life-saving Opioid overdose antidote, Naloxone (Narcan), should be made available over-the-counter (OTC). The meeting consisted of two federal panels of addiction experts, the FDA’s Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee.

The Baltimore, Maryland company Emergent BioSolutions Inc. was responsible for filing the application to the FDA in late 2022 to sell their generic Naloxone hydrochloride without a prescription, marking the first such application of a Naloxone-based spray. In Wednesday’s hearing, both panels unanimously recommended that Narcan be made widely available without a prescription. They say it would be a “major step forward in the effort to stem skyrocketing drug fatalities.”

Understanding Narcan

Naloxone has been around for over 50 years and is a well-known Opioid overdose reversal agent. It was first approved for use by the FDA in 1971, where it was utilized primarily by first responders and frontline hospital workers to resuscitate patients who may have otherwise died from an overdose.

Narcan is an Opioid antagonist, meaning it works by blocking the effects of Opiates on the brain. Opiates can depress the respiratory system and other vital bodily functions such as heart rate or brain function. By interrupting these effects, Narcan can wake a person from a severe Opioid overdose.

Why Making Narcan Widely Available Would Save Lives

Documents submitted by Emergent to the FDA argue that its Narcan nasal spray has been designed specifically for people with little to no medical training. The panel also noted that the nasal spray, if available OTC, would be “as easily available as ibuprofen,” and also noted that it “is abundantly safe and effective even in infants, with almost no potential for misuse or abuse.”

Since 1999, more than 564,000 people have died from Opioids in the US, of which nearly 40% (229,000) have occurred in the last three years.

“Each day 187 people will die — this is absolutely tragic as we think of not only the individuals themselves, but the families, the communities, the workplaces. This has profound human impact, and we are all impacted from this,” Manish Vyas, senior vice president of regulatory affairs at Emergent BioSolutions, told the committee.

While Narcan is available in all 50 states, many of which allow pharmacists to issue what is known as a “standing order,” meaning they can dispense Narcan without a prescription, many barriers still prevent it from being easily attainable to the general public.

Some of these barriers include how Narcan is sold in the US. While many states offer Narcan without needing a prescription, with many running free Narcan programs, it still must be obtained by a pharmacist. This may seem like a minor barrier; however, due to the stigma toward people who use drugs, pharmacists are often reluctant to carry supplies or engage with consumers, who may become hesitant to ask for Narcan.

“If naloxone becomes a nonprescription product, it may be sold in many venues previously unavailable to consumers, including vending machines, convenience stores, supermarkets and big-box stores, just like other nonprescription products,” Jody Green, an official at the FDA’s Nonprescription Drug Division, told the advisory committee Wednesday.

How Much Will Over-The-Counter Narcan Cost?

According to statements by Emergent, the company has yet to disclose how much the life-saving medication will cost should the FDA approve it for OTC use.

“We have been working on distribution plans with key stakeholders like retailers and government leaders,” said Matt Hartwig, a spokesperson for the company.

Many believe that making Narcan available OTC could help decrease the price, which currently sits at a nationwide average of $176 for a supply of two sprays. However, others believe that if insurance companies stop covering Narcan, it could reduce availability to those who may not be able to afford it.

These concerns aside, experts agree that an OTC Narcan nasal spray is a good idea.

When Will The FDA Make Its Decision?

While the FDA’s hearing on Narcan is promising, the agency has yet to rule on the matter officially. With that said, however, the FDA is expected to decide by March 29 on whether the 4-milligram nasal spray should be able to be purchased without a prescription. While the FDA is not required in any way to accept the recommendations made by experts, given the agency’s past rulings, they likely will.

Emergent BioSolutions said Narcan would be available for the OTC market by late summer if the FDA approves it next month. To learn more about where you can find Narcan, visit your state’s department of health directory for more information about regulations and prescription status.

Get The Help You Need Today

It’s important to remember that while Narcan can be a life-saving medication in the event of a drug overdose, it is not a one-and-done treatment. After administering Narcan, it is vital to contact 911, even if the person wakes up. This is because the signs and symptoms of an Opioid overdose can return after Narcan is administered, and without further treatment could be life-threatening.

Additionally, it’s essential to take the necessary steps to ensure that your need for Narcan is as close to zero as possible. Overdoses can occur at any time, regardless of your history of drug use or the amount of substance used. However, overdoses, especially when recurrent, can also be a sign of a severe substance use disorder.

If you or someone you know is struggling with a substance use disorder and needs help, know that help is available. To learn more about your treatment options, contact a treatment provider today to start your recovery journey.