SRI receives FDA clearance to initiate high-dose naloxone clinical trial

June 10, 2025 03:25 PM AEST | By EIN Presswire
 SRI receives FDA clearance to initiate high-dose naloxone clinical trial
Image source: EIN Presswire
MENLO PARK, CA, UNITED STATES, June 10, 2025 /EINPresswire.com/ -- SRI announced today that the U.S. Food and Drug Administration (FDA) authorized the Phase 1 clinical trial of a new naloxone formulation under an Investigational New Drug (IND) application. The trial will evaluate SRI’s high-dose naloxone formulation for intravenous and intramuscular use.

Deaths involving synthetic opioids rose by more than 700% between 2015 and 2022, according to the National Center for Health Statistics. SRI is addressing this by developing an injectable formulation of naloxone designed to provide a rapid and sustained reversal of opioid overdose, particularly in cases involving ultra-potent synthetic opioids such as fentanyl, nitazenes, and carfentanil. These are increasingly present in the illicit drug supply and are associated with difficult-to-reverse overdoses using today’s naloxone products.

“Given the current low-dose naloxone formulations, they’re not as effective for the kinds of synthetic opioids we’re seeing today,” said Gita Shankar, senior director of the Pharmaceutical Sciences Lab at SRI. “Our new formulation is a single high-dose naloxone shot that first responders can inject into victims when there is a risk of death.”

When someone overdoses today, it often leads to oxygen deprivation, coma, and even death. Naloxone (also known by the brand name Narcan) can reverse this by blocking receptors in the brain and displacing opioids that are binding to receptors. “The problem is that Narcan lasts about 90 minutes,” Shankar said. “It drops off, and opioids can re-bind to those receptors, resulting in a recurrence of overdose symptoms, and the person can stop breathing again. Giving our higher dose treatment can reduce the effects of a deep overdose.”

To address the limitations of current treatments, SRI developed a highly concentrated naloxone formulation that delivers 10 times more naloxone per milliliter than today’s products. The formulation is optimized for systemic availability and shelf stability, making it more suitable for emergency use. “In the hands of emergency responders, this has the potential to address the synthetic opioid overdose crisis head-on and save more lives,” Shankar concluded.

About SRI
SRI is an independent nonprofit research institute headquartered in Menlo Park, Calif., with a rich history of supporting government and industry. We create and deliver world-changing solutions for a safer, healthier, and more sustainable future. For nearly 80 years, we have collaborated across technical and scientific disciplines to discover and develop groundbreaking products and technologies and bring innovations and ideas to the marketplace. Learn more at www.sri.com.

The effort was sponsored by the U.S. Government under Transaction number W15QKN-16-9-1002 between the MCDC and the U.S. Government. The U.S. Government is authorized to reproduce and distribute reprints for governmental purposes, notwithstanding any copyright notation thereon. The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government.

Kelly M Brieger
https://www.linkedin.com/company/sri-international/mycompany
[email protected]
Visit us on social media:
LinkedIn
YouTube

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.


Disclaimer

The content, including but not limited to any articles, news, quotes, information, data, text, reports, ratings, opinions, images, photos, graphics, graphs, charts, animations and video (Content) is a service of Kalkine Media Pty Ltd (“Kalkine Media, we or us”), ACN 629 651 672 and is available for personal and non-commercial use only. The principal purpose of the Content is to educate and inform. The Content does not contain or imply any recommendation or opinion intended to influence your financial decisions and must not be relied upon by you as such. Some of the Content on this website may be sponsored/non-sponsored, as applicable, but is NOT a solicitation or recommendation to buy, sell or hold the stocks of the company(s) or engage in any investment activity under discussion. Kalkine Media is neither licensed nor qualified to provide investment advice through this platform. Users should make their own enquiries about any investments and Kalkine Media strongly suggests the users to seek advice from a financial adviser, stockbroker or other professional (including taxation and legal advice), as necessary.
The content published on Kalkine Media also includes feeds sourced from third-party providers. Kalkine does not assert any ownership rights over the content provided by these third-party sources. The inclusion of such feeds on the Website is for informational purposes only. Kalkine does not guarantee the accuracy, completeness, or reliability of the content obtained from third-party feeds. Furthermore, Kalkine Media shall not be held liable for any errors, omissions, or inaccuracies in the content obtained from third-party feeds, nor for any damages or losses arising from the use of such content.
Kalkine Media hereby disclaims any and all the liabilities to any user for any direct, indirect, implied, punitive, special, incidental or other consequential damages arising from any use of the Content on this website, which is provided without warranties. The views expressed in the Content by the guests, if any, are their own and do not necessarily represent the views or opinions of Kalkine Media. Some of the images/music that may be used on this website are copyrighted to their respective owner(s). Kalkine Media does not claim ownership of any of the pictures displayed/music used on this website unless stated otherwise. The images/music that may be used on this website are taken from various sources on the internet, including paid subscriptions or are believed to be in public domain. We have made reasonable efforts to accredit the source wherever it was indicated as or found to be necessary.
This disclaimer is subject to change without notice. Users are advised to review this disclaimer periodically for any updates or modifications.


AU_advertise

Advertise your brand on Kalkine Media

Sponsored Articles


Investing Ideas

Previous Next
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.