FDA Approves Narcan for First Over-the-Counter Sales

April 17 20:24 2023
Narcan Expected to Reduce Opioid Deaths

The U.S. FDA recently approved Narcan nasal spray for over-the-counter sales in 4 milligram (mg) doses without a prescription. Narcan is a brand of naloxone, a life-saving medication that rapidly reverses an opioid related overdose. 

The Allen Research Endowment, headquartered in Greenwich, CT, provided a comment letter to the FDA’s Office of Regulatory Policy for Naloxone Federal Register Notice 2022-N-2673. In summary, the charities’ comment letter urged the FDA to approve naloxone for over-the-counter sales to reduce ongoing opioid overdose deaths in the U.S.  

To view the FDA release, please see: https://www.fda.gov/news-events/press-announcements/fda-approves-first-over-counter-naloxone-nasal-spray

The Allen Research Endowment believes the FDA’s approval of over-the-counter (“OTC”) Narcan will be a game changer and save lives. Narcan is the standard treatment in the healthcare industry to    reverse the effects of an opioid overdose, including synthetic opioids such as fentanyl. Now, consumers will be able to keep a Narcan nasal spray on hand, which can save the life of someone who accidently overdoses. 

Many people do not realize that opioids continue to be the “standard of care” at hospitals for pain management. Unfortunately, until this changes, the Allen Research Endowment believes opioid related addiction and overdoses will continue. 

Below are answers to questions from consumers interested to learn more about Narcan as provided by the CDC, National Institutes of Health and other government agencies. Disclaimer: Please check with a healthcare provider for professional answers to specific situations.  

Q1. “What is naloxone?”
A1. It is a life-saving medication that can reverse the effects of an overdose from opioids including    heroin and fentanyl.

Q2. “What is the shelf-life of naloxone?”
A2. Depending on the specific brand, in general, about 2 – 3 years.   

Q3. “What is the expected cost of Narcan nasal spray?”
A3. Narcan is a brand for naloxone hydrocholoride. For two doses, expect a price around $50.  

Q4. “When and where can I buy Narcan?”
A4. Expect OTC Narcan nasal spray to be available in August 2023 at pharmacies, grocery stores, gas stations and online.     

Q5. “How do you administer Narcan nasal spray?”
A5. Call 911 and while waiting for medical professionals to arrive, tilt overdosing person’s head back as they lay down on back to open nasal channels

–  Remove wrapper of nasal spray, place tip of nasal spray into one of the nostrils of the person,
–  Hold the nasal spray with a hand, and thumb – push out the spray into the nostril
–  Wait 2-3 minutes for the person to start breathing again
–  If the person is still not breathing, administer another dose – into the other nostril. Repeat.

Q6. “What should I do if overdosing person initially recovers, then later, starts overdosing again?”
A6. Since the opioid’s effective time period is longer than Narcan’s, repeat the Narcan spray process again into the overdosing person’s nostrils as described above.        

Q7. “How do I know when someone is overdosing?”
A7. First, don’t leave the person alone. If they are conscious, walk them around, keep them awake and monitor their breathing. 

Then, look for any of the following signs:

–  Loss of consciousness
–  Awake but unable to talk or respond to stimulus (i.e. to shouting or loud handclaps)
–  Breathing is very slow, erratic or has stopped
–  Vomiting
–  Body is very limp 
–  Fingernails and lips turn blue or purplish black
–  Pulse (heartbeat) is slow, erratic or not there as all.

Q8. “Is Narcan nasal spray easy to use?”
A8. Yes. Its use is similar to a typical nasal spray. 

Q9. “Can I use Narcan on myself?”
A9. No, Narcan cannot be used prior to taking drugs. Also, when a person overdoses, they cannot breath and will be unconscious. 

Q10. “Can I keep Narcan nasal spray in my car?” 
A10. In general, Narcan nasal spray can be kept in places with a temperature range of 59-86 °F and not in direct sunlight.    

For further information, please email [email protected], visit https://allenrsch.org/ or mail to Allen Research Endowment, Inc., 500 West Putnam Avenue, Suite 400, Greenwich, CT 06830.                 

About the Allen Research Endowment

The Allen Research Endowment, Inc., based in Greenwich, CT, is a Delaware 501(c) (3) tax-exempt organization focused on developing non-opioid, non-addictive pain management drugs, faith-based education and public policy. Its mission is to save lives of persons with opioid and related addictions. At least 80% of every dollar donated goes directly to its mission.  https://allenrsch.org/.

2023 Copyright Allen Research Endowment, Inc. All rights reserved. EIN 81-4117507.

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