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Narcan Approved for Over-the-Counter: What to Know

Cartoon image of Narcan over the counter at a pharmacy

More than 100,000 lives are lost to drug overdoses in the U.S. each year, with synthetic opioids, such as illicit fentanyl, accounting for over 80% of these deaths. Narcan (naloxone hydrochloride) is the standard treatment for an opioid overdose. This life-saving medication rapidly reverses the life-threatening effects of a known or suspected opioid overdose. It was previously available by prescription only, but as of late March 2023, it has been approved by the U.S. Food and Drug Administration (FDA) for over-the-counter (non-prescription) use.

Narcan: Life-Saving Opioid Overdose Treatment

Narcan nasal spray (naloxone hydrochloride) is the first opioid overdose product that will be available directly to consumers, without a prescription, at locations like drug stores, grocery stores, and convenience stores. They may even be available for purchase online, at gas stations, big box retailers, and even vending machines. It is expected to be on the shelves by late summer 2023.

The FDA allows an Rx-to-OTC (prescription to nonprescription) switch if a drug manufacturer can demonstrate that it can be safely used without supervision by a healthcare provider. Notably, only the 4 mg nasal spray, sold under the brand name Narcan, has been approved for OTC use. Other forms of the medicine, including injections, auto-injectors, and higher doses of the nasal spray, will remain prescription-only.

Narcan is approved for use in adults and children and is given as needed to treat a known or suspected opioid overdose. Each Narcan nasal spray contains a single dose and can be used only once. More medications would need to be purchased to provide multiple doses. 

“The recent FDA approval of over-the-counter Narcan nasal spray marks a huge achievement in public health and emergency medical care,” said BuzzRx CEO & Founder, Matt Herfield. “The wide availability will hopefully prevent thousands of deadly opioid overdoses every year.”

How Does Narcan Work to Reverse Opioid Overdoses?

A person experiencing an opioid overdose cannot give themselves Narcan. Therefore, it’s important that family members and other people they spend time with carry naloxone and know when and how to use the nasal spray, and what to do until emergency medical care arrives to reverse overdoses. 

Signs and symptoms of an opioid overdose can include excessive drowsiness, unresponsiveness, small pupils, and shallow or stopped breathing. Narcan nasal spray is administered with the person lying on their back with the neck supported and the head tilted back. The nozzle of the nasal spray is placed in one nostril, and the plunger is pressed firmly to release the medicine. The person is then turned onto their side into the recovery position. The person who administers naloxone should call 911 after giving a dose of the medicine to a person experiencing an opioid overdose.

“It’s a relief to see Narcan made widely available to help further combat the epidemic of opioid overdose deaths in our country,” said HaVy Ngo-Hamilton, Pharm.D., clinical consultant at BuzzRx. “I encourage pharmacists and medical professionals to inform and demonstrate proper usage and administration of the Narcan treatment as it reaches our communities.”

Naloxone Hydrochloride Nasal Spray Side Effects

Narcan nasal spray can cause side effects such as nasal dryness, swelling, congestion, headache, and muscle aches. More serious side effects of naloxone include severe opioid withdrawal symptoms such as body aches, nausea, vomiting, diarrhea, stomach cramps, fast or irregular heartbeats, sweating, shivering, sneezing, yawning, restlessness, nervousness, irritability, weakness, and hair-standing on end. While these side effects can be severe, the benefits of using naloxone (Narcan) outweigh the risks. 

Fortunately, giving naloxone to a person who has not taken opioids or other drugs does not cause any harm. So, in case it’s unclear whether a person is experiencing an opioid overdose, it’s better to err on the side of caution and give naloxone.

How Much Will Over-the-Counter Narcan Cost?

The FDA has done its part by approving OTC Narcan 4 mg nasal spray (naloxone hcl) to facilitate easier access to this emergency treatment and life-saving medicine. Addressing this public health need will hopefully lower the number of drug overdose deaths in the country. It’s up to the manufacturer now to make OTC Narcan available as soon as possible at an affordable price.

Health economists predict that the cost of OTC Narcan will likely be somewhere between $35 and $65 plus the retailer’s markup, so the price may prove to be a hurdle in easy access to this life-saving medication.

“We hope that with this historic announcement comes the decision to prioritize making this life-saving treatment affordable and accessible to everyone,” said Herfield.

While the public awaits Narcan to hit shelves, generic naloxone can be discounted over $17 off the retail price with a BuzzRx coupon. The price for one non-aerosol nasal spray in the 4 mg dose is under $55.00 at CVS or around $59.00 at other major chains, including Walgreens, Rite Aid, Kroger, and Publix. You will still need a doctor’s prescription through the end of the summer until available over the counter. 

 

References:

  1. https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray
  2. https://www.cdc.gov/drugoverdose/deaths/synthetic/index.html
  3. https://medlineplus.gov/druginfo/meds/a616003.html
  4. https://www.fda.gov/drugs/drug-application-process-nonprescription-drugs/prescription-nonprescription-rx-otc-switches#