AcelRx Pharmaceuticals, a Redwood City, Calif.-based specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, has entered into a contract worth up to $17 million supported by the U.S. 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 III clinical, manufacturing and regulatory activities. ARX-04 is in development as a non-invasive, single-use, 30mcg 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 III study of ARX-04 and now are 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 III development program, continue with manufacturing activities and ready the product for the potential submission of an NDA. We are excited to continue our relationship with the DoD, which began in 2011 through a $5.6 million grant to fund phase II development. We believe ARX-04 potentially can 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," said Howie Rosen, AcelRx interim CEO.
The contract begins 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 III clinical program and manufacturing development activities over the next 18-months.