Narcan: FDA allows opioid overdose drug to be sold over the counter

The news comes as drug-overdose deaths have hit record highs in the US.

ISLAMABAD, (Online) - The US Food and Drug Administration has approved the opioid-antidote naloxone known by its brand name Narcan to be sold over the counter (OTC).

The news comes as drug-overdose deaths have hit record highs in the US.

“Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country,” FDA Commissioner Dr. Robert M. Califf said in a statement.

“We encourage the manufacturer to make accessibility to the product a priority by making it available as soon as possible and at an affordable price.”

A panel of advisors to the Food and Drug Administration unanimously voted in February to recommend that naloxone or Narcan nasal spray be sold over the counter (OTC).

The panel consisted of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. Naloxone, more commonly known by its brand name Narcan, is a drug used to reverse some of the effects of opioid overdose.

What is naloxone?

When it is administered, the naloxone binds with the opioids to stop the slowing of breathing that accompanies opioid use and blocks the drug from causing further symptoms.

The drug can be given through a nasal spray or through injection into muscle, under the skin, or directly into a vein.

Since naloxone only works for a short period of time, anyone who has overdosed needs medical attention even after the administration of naloxone. It has no effects on those who have not taken an opioid.

The American Medical Association (AMA) and the American Pharmacists Association support making naloxone more widely available in order to save lives.

Dr. Bobby Mukkamala,Trusted Source Chair of the AMA Substance Use and Pain Care Task Force, called for making naloxone available OTC as a vital step.

“This will help community-based organizations purchase and distribute naloxone to those who need it most. Rather than sitting behind a pharmacy counter, naloxone needs to be readily available to save lives,” said Mukkamala. “The AMA believes greater access will occur when naloxone for overdose risk is just as easily accessible in a pharmacy, grocery store and other common locations as acetaminophen for a headache or a decongestant for a stuffy nose.”

Naloxone can be difficult to obtain

While naloxone is supposed to be available in pharmacies without a prescription in all states but Hawaii, it was not an over-the-counter drug. Instead, it was often considered a behind-the-counter drug meaning you likely had to talk to the pharmacist to obtain it.

A 2020 study found that while many pharmacists had been asked about opioid abuse and overdose and needle exchange programs, they often could not provide any information on those programs, treatment, or what to do in event of an overdose, although 83% agreed that this information was needed.

By making naloxone available for OTC use, it can be purchased without the need for a pharmacist or medical professional to dispense it.

Dr. Tucker Woods, the chair of the emergency department and associate medical director of Lenox Health Greenwich Village, board certified in addiction medicine, said in a previous interview making naloxone available OTC could be a huge help in fighting the rise of deadly overdoses.

“We are currently experiencing the highest number of opioid overdose deaths that the country has ever seen,” Woods said. “Naloxone is an extremely effective medication that reverses an opioid overdose; in other words, naloxone is an antidote to opioid overdose. Previously naloxone was only available with a prescription. By making it available as an over-the-counter medication, we will be able to expand access and get naloxone into more hands. This is an effective public health approach that will ultimately save more lives given the scope of the opioid epidemic.”

If people learn how to spot the signs of overdose and what to do next, having easily available naloxone could mean that anyone can take steps to save the life of a person experiencing a potentially deadly overdose. A 2020 study took 710 adults and trained them to recognize the signs of opioid overdose as well as when and how to administer naloxone (through nasal spray or injection). The researchers found that almost 80% were able to understand and implement the training when needed.

Record high number of deaths

Fatalities related to opioids have reached record highs in recent years.

An estimated 80,250 people died from opioid overdose in 2021.

To combat these rising rates the FDA has taken steps to help improve access to life-saving medication like naloxone.

These include increasing the shelf life of naloxone from 24 months to 36 months and requiring manufacturers of any medication containing opioids to include information about naloxone in medication prescription information.

They have also recommended that anyone currently taking an opioid pain relieverTrusted Source have a prescription for naloxone as well.

Several different things need to be done to ready naloxone for OTC use. A drug facts label that explains the dose per nasal spray or autoinjector and what is the active ingredient must be prepared. Pictograms describing how to use naloxone and when also may be added.