JAN 05, 2023 11:23 AM PST

Potential Over-the-Counter Access to Naloxone- a life saving drug

WRITTEN BY: Greta Anne

Naloxone is a powerful FDA-approved opioid antagonist that works to reverse life-threatening opioid overdoses. Since it is an opioid antagonist, it works by reversing and blocking the effects of opioids. Commonly misused opioids include heroin, hydrocodone, and morphine. The opioid crisis is a nationwide epidemic, with opioid-related deaths at an all-time high. The COVID-19 pandemic has made the opioid epidemic even worse due to the anxiety, depression, and loneliness experienced during it. Furthermore, it places an additional burden on healthcare workers, such as first responders, nurses, doctors, pharmacists, along with law enforcement officers, government officials, insurance companies, and more. 

Currently, naloxone is only available from a pharmacy; however, it can be purchased without a prescription from a provider. This essentially forces patients into going to a pharmacy during a suspected opioid overdose in order to gain access to naloxone, which may result in time lost in saving a life. 

Harm Reduction Therapeutics (HRT) is a nonprofit pharmaceutical company looking to reduce the incidence of opioid overdoses. They have developed a new drug, RiVive, which is 3mg intranasal naloxone, delivered in a single-dose administration. See the video below on how to administer intranasal naloxone in the case of an emergency. 

 

The FDA has been asking for a company to develop over-the-counter naloxone, and Harm Reduction Therapeutics has been working on this project for around 5 years. Access to over-the-counter naloxone is revolutionary since more stores would be empowered to carry it, such as gas stations, bodegas, shopping centers, and grocery stores. HRT’s Phase I clinical trial shows that RiVive produced 3 times more systemic exposure of naloxone than their control naloxone product, meaning that RiVive was more effective than their control. 

RiVive is anticipated to launch in early 2024.

 

References:

https://www.samhsa.gov/medication-assisted-treatment/medications-counseling-related-conditions/naloxone

https://www.mayoclinic.org/drugs-supplements/naloxone-nasal-route/proper-use/drg-20165181

https://scdhec.gov/opioid-epidemic

About the Author
Bachelor's (BA/BS/Other)
Greta is currently a writer at Labroots and a 3rd year Doctor of Pharmacy student, with a Bachelor of Science degree in Physiology and Neurobiology. Innovation is her passion, especially when it comes to pharma, entrepreneurship, science, and art. She is hoping to pursue a career in pharma while also fostering her creative initiatives.
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