SBIR-STTR Award

Dual Formulation of Atropine-Scopolamine with Enhanced Stability
Profile last edited on: 6/26/2019

Program
SBIR
Agency
CBD
Total Award Amount
$1,111,810
Award Phase
2
Principal Investigator
Michael Radomsky
Activity Indicator

Company Information

Cmc Pharmaceuticals Inc (AKA:CMC CONSULTING )

7100 Euclid Avenue Suite 152
Cleveland, OH 44103
   (216) 242-4571
   N/A
   www.cmcpharm.com
Multiple Locations:   
Congressional District:   11
County:   Cuyahoga

Phase I

Phase I year
2019
Phase I Amount
$149,269
CMC Pharmaceuticals, Inc. (Cleveland, OH) is proposing developing a stable, combination product of two small molecule drug candidates as acounter measure to chemical warfare nerve agents (NA). The combination product is expected to exploit complementary pharmacologicalprofiles for optimal muscarinic receptor blockade and anticholinergic activity within the peripheral and central nervous system. It is expectedthat the development of this stable, combined formulation will increase the therapeutic efficacy over current NA treatment regimens. CMCPharma proposes a pharmaceutical research and development program to develop preliminary specifications of this combination formulationto meet FDA and ICH development guidelines. The specific aims include the development of a stability indicating analytical method,identification of promising prototype formulations, and determination of the initial stability-profiles of the proposed prototype formulations.Previous research at CMC Pharma that identified methods and formulation approaches for similar small molecule drug candidates will beutilized. This early stage research and development effort is expected to proceed to bridge the gap between laboratory-scale innovation (i.e.This effort) and entry into an FDA regulatory pathway leading to commercialization.

Phase II

Phase II year
2020 (last award dollars: 2020)
Phase II Amount
$962,541
CMC Pharmaceuticals, Inc. (Cleveland, OH) has proposed developing a stable, combination product of two small molecule drug candidates as a countermeasure to chemical warfare nerve agents (NA). The combination product is expected to exploit complementary pharmacological profiles for optimal muscarinic receptor blockade and anticholinergic activity within the peripheral and central nervous system. It is expected that the development of this stable, combined formulation will increase the therapeutic efficacy over current NA treatment regimens. CMC Pharma proposes a pharmaceutical research and development program to develop preliminary specifications of this combo product to meet FDA and ICH development guidelines. The specific aims of the SBIR-phase II submission include the development of stability indicating analytical methods, identification of promising prototype formulations, and determination of the stability-profiles of the proposed prototype formulations for up to 24 months. Previous research at CMC Pharma that identified methods and formulation approaches for similar small molecule drug candidates will be utilized. This early stage research and development effort is expected to proceed to bridge the gap between laboratory-scale innovation (i.e. this effort) and entry into a FDA regulatory pathway leading to commercialization.