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Concentrated Atropine Sulfate Formulations

Award Information
Agency: Department of Defense
Branch: Special Operations Command
Contract: H9240522P0002
Agency Tracking Number: S213-002-0032
Amount: $149,997.42
Phase: Phase I
Program: SBIR
Solicitation Topic Code: SOCOM213-002
Solicitation Number: 21.3
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-01-20
Award End Date (Contract End Date): 2022-07-24
Small Business Information
12345 W. 52nd Ave.
Wheat Ridge, CO 80033-1916
United States
DUNS: 181947730
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 Girish Srinivas
 (303) 940-2321
Business Contact
 Mr. John D. Wright
Phone: (303) 940-2300
Research Institution

Organophosphorus nerve agent attacks are an unfortunate reality of modern warfare. Currently, the standard of care is to use up to three sequential doses of the Antidote Treatment Nerve Agent Autoinjector (ATNAA, which contains atropine sulfate, and 2-pyridine aldoxime chloride (2-PAM)) and an anticonvulsant. For severe cases, this is followed by continued dosing of atropine to block muscarinic effects, up to 50-100 mg over 24 hours. However, the maximum concentration of commercially available multi-dose atropine sulfate in the US is 0.4 mg/mL and requires up to 13 vials to treat a single patient. This is logistically demanding to transport and maintain. It would be far better to supply concentrated atropine sulfate, using a single vial to treat the most severely poisoned soldiers. TDA proposes development of a concentrated atropine sulfate formulation of 5-10 mg/mL supplied in a 10-20 mL multi-dose vial with a shelf life of at least 2 years. In Phase I TDA will formulate this drug product, perform quality testing and stability studies, and prepare a pre-submission package for the FDA. This will be in support of product refinement and full testing in Phase II, followed by commercial process development, validation, and FDA registration in Phase III.

* Information listed above is at the time of submission. *

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