​AcelRx Pharmaceuticals, Inc. , a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced it has entered into Contract No. W81XWH-15-C-0046 worth up to $17.0 million, supported by the United States Army Medical Research and Materiel Command (USAMRMC) within the U.S. Department of Defense (DoD). The contract provides partial funding for ongoing development of ARX-04, including Phase 3 clinical, manufacturing and regulatory activities. ARX-04 is in development as a non-invasive, single-use 30 mcg sufentanil sublingual tablet in a disposable, pre-filled, single-dose applicator (SDA), for the anticipated treatment of moderate-to-severe acute pain in a medically supervised setting. 

 

“We recently announced the initiation of the pivotal Phase 3 study of ARX-04 and are now very pleased to announce the DoD’s continued support of ARX-04. 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 (NDA). We are excited to continue our relationship with the DoD, which began in 2011 through a $5.6 million grant to fund Phase 2 development. We believe ARX-04 can potentially provide great benefit to our servicemen and women in the armed forces and presents promising commercial opportunities in a wide range of medically-supervised settings such as emergency rooms, and following short-stay surgeries,” stated Howie Rosen, AcelRx interim Chief Executive Officer. 

 

Under the terms of the contract, commencing in Q2 2015, the DoD 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. 

 

Source: AcelRx Pharmaceuticals