MENLO PARK, CA (December 8, 2021)— SRI Biosciences has been awarded a $14.7 million contract sponsored by the Defense Threat Reduction Agency (DTRA) through the Medical, Chemical, Biological, Radiological, and Nuclear Defense Consortium (MCDC) to continue development of a high-concentration naloxone product for intravenous, intramuscular and subcutaneous injection, or intravenous infusion.
Under the three-year contract, SRI will advance their in-development naloxone product from an Investigational New Drug (IND) application to a U.S. Food and Drug Administration New Drug Application (NDA), with the ultimate objective of commercializing and licensing the new formulation as a countermeasure for individuals who have received toxic doses of ultra-high potency synthetic opioids.
The Department of Defense (DoD) has identified a need for a high-dose naloxone in a multi-use vial format to curb the current concerns associated with ultra-high-potency synthetic opioids. According to the Centers for Disease Control and Prevention (CDC), synthetic opioids (primarily illicitly manufactured fentanyl) appear to be the primary driver of overdose deaths in the United States, which increased 38.4 percent between the 12 months leading up to June 2019 and the next 12-months leading up to May 2020. The potential of a mass casualty public health event involving ultra-high potency synthetic opioids is an increasing concern as well. These opioids pose a challenge for both military and civilian populations, including first responders. While naloxone is known to be an effective antidote to opioid overdose, higher doses than those currently available are required to treat individuals who have received toxic doses of synthetic opioids.
Under a previous contract, SRI developed a high-concentration naloxone formulation that can be made available in a large vial designed to deliver multiple doses. The new award will advance this formulation to U.S. market approval. When caring for individuals exposed to highly potent synthetic opioids, SRI’s naloxone injection will enable medics and other clinicians to rapidly deliver 10-mg doses as needed to resuscitate patients and treat opioid-induced respiratory depression. The multi-dose vial enables medical staff to deliver additional doses in the event of re-narcotization, which is common with synthetic opioid overdoses.
“SRI is grateful for DTRA’s continued support on this important and impactful project,” said Gita Shankar, Ph.D. senior director of Pharmaceutical Sciences at SRI and leader of the program. “We look forward to delivering this high-concentration naloxone formulation to help protect our military and frontline responders.”
This effort is sponsored by the U.S. Government under Other Transaction number W15QKN-16-9-1002 between the MCDC, and the Government. The US 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.
About SRI Biosciences
SRI International, a non-profit research institute founded in 1946 and headquartered in Menlo Park, California, creates world-changing solutions to make people safer, healthier, and more productive. SRI Biosciences, a division of SRI International, integrates basic biomedical research with drug and diagnostics discovery, and preclinical and clinical development. SRI Biosciences has advanced more than 175 drugs to clinical trials, and approximately 20 have reached the market. The division is focused on novel platforms and programs in a variety of therapeutic areas targeting high unmet medical needs. SRI Biosciences collaborates with a broad range of partners from small and virtual biotechnology companies to top 10 pharmaceutical companies and other leading industry partners. More information is available at www.sri.com.
SRI International creates world-changing solutions making people safer, healthier and more productive. SRI, a research center headquartered in Menlo Park, California, works primarily in advanced technology and systems, biosciences, computing and education. SRI brings its innovations to the marketplace through technology licensing, spin-off ventures and new product solutions.