AcelRx Pharmaceuticals won a $5.6 million grant from the U.S. Army Medical Research and Material Command (USAMRMC) to fund a Phase II clinical trial with its sublingual sufentanil analgesic candidate ARX-04. Based on AcelRx’ NanoTab® technology, ARX-04 is a single-dose, higher strength formulation of the firm’s ARX-01 patient-controlled analgesia candidate.
The Phase II ARX-04 study, which is due to start during the second half of 2011, will evaluate two doses of NanoTab sufentanil in patients suffering from moderate-to-severe pain, to determine the best dose to take through to Phase III studies.
The firm says that while intramuscular injections for pain relief are the current standard of care on the battlefield, they can be associated with an increased risk of infection. Moreover, in patients with severe trauma in hypovolemic shock, reduced perfusion of muscles means pain relief injected intramuscularly may not readily reach the bloodstream. Conversely, oral pills and liquids generally have a slow and erratic onset of analgesia. In addition to its applications for pain relief in battlefield casualties, ARX-04 could also have utility in a range of medically supervised settings, AcelRx points out.
AcelRx is focused on the development and commercialization of products for the treatment of acute and breakthrough pain. Lead sufentanil-based candidate ARX-01 is a noninvasive, sublingual, patient-controlled analgesia (PCA) system. Currently being prepared for Phase III studies, the product has successfully completed three Phase II placebo-controlled trials in patients undergoing elective unilateral knee replacement surgery and major abdominal surgery, and an open-label Phase II system functionality study evaluating the handheld component of ARX-01 in unilateral knee replacement surgery. The handheld PCA device is designed to enable simple patient-controlled delivery of NanoTabs in the hospital setting.
Additional clinical-stage candidates ARX-02 and ARX-03 have also completed Phase II development. ARX-02 Sufentanil NanoTab BTP Management System is in development for use by cancer patients experiencing breakthrough pain (BTP). The complete product comprises a magazine containing 30 single-dose applicators, or SDAs, each containing a NanoTab sufentanil tablet, loaded into a multiple SDA smart dispenser. Designed to allow patient self-administration of the sublingual tablets, the dispenser displays a recent dose indicator designed to help prevent overdosing, and provides electronic date and time stamping of each SDA removal event. The date and time event log is designed to be retrieved from the MSD by a healthcare professional during an office visit.
ARX-03 is a physician- or nurse-administered combination of sufentanil and triazolam, which is designed to provide mild sedation, anxiety reduction, and pain relief for patients undergoing painful procedures in a physician’s office.