AcelRx Pharmaceuticals said it has won contract worth up to $17 million from the United States Army Medical Research and Material Command to advance the development of its ARX-04 treatment of moderate-to-severe acute pain in a medically supervised setting.
The drug is ARX-04 is in development as a non-invasive, single-use 30 mcg sufentanil sublingual tablet in a disposable, pre-filled, single-dose applicator.
“The funding, together with our existing resources, will allow us to complete the Phase 3 development program, continue with manufacturing activities, and ready the product for the potential submission of a New Drug Application,” CEO Howie Rosen said in a statement.
Under the terms of the contract, the Department of Defense will reimburse AcelRx for costs incurred for development, manufacturing and clinical costs outlined in the contract, including reimbursement for certain personnel and overhead expenses. These development activities are intended to include completion of the Phase 3 clinical program and manufacturing development activities over the next 18-months.