AcelRx reports topline results from SAP302 trial
The trial, which was single-arm and open-label, evaluated ARX-04 in patients who were admitted to the emergency room due to moderate-to-severe acute pain related to trauma or injury. The 76 adult patients treated with ARX-04 experienced a mean pain intensity difference to baseline (PID) of 2.9, which is significantly lower than the 8.1 baseline.
"The Department of Defense, which has provided us with development funding for ARX-04, suggested that we conduct a cognitive impairment assessment to determine if ARX-04 causes cognitive deficiencies, which is an understandable concern when treating wounded soldiers on the battlefield," AcelRx Pharmaceuticals co-founder and CMO Dr. Pamela Palmer said. "In addition to putting combat units in danger, drug-induced cognitive effects can impede diagnosis and treatment in a civilian emergency room. If borne out, ARX-04's onset of pain relief, sublingual dosage form and side effect profile could make it an attractive option for doctors considering opioid analgesic treatment in emergency rooms and field-based settings."