US-based specialist pharmaceutical company AcelRx has reported positive topline results from its Phase III SAP302 trial of ARX-04 to treat trauma or injury related, moderate-to-severe acute pain.
ARX-04 is developed as a non-invasive, investigational product candidate consisting of 30mcg sufentanil tablets delivered sublingually through a disposable, pre-filled, single-dose applicator (SDA).
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The Phase III SAP302 trial was designed as a single-arm, open-label study divided into two cohorts.
The first cohort included 40 adult patients administered with a single dose of ARX-04, while the second cohort included 36 adult patients who were treated with four doses of ARX-04 given on an hourly basis, depending on pain levels.
The interim results of the first cohort were reported in February and recorded a baseline change in the density pain for patients treated with ARX-04.
Results of the second cohort also reported a baseline change in the pain density, in which 75% of the patients experienced pain relief with a single dosage of ARX-04 with 8% of patients requiring to receive morphine in addition to ARX-04.
Additionally, the ARX-04 also predicted the beginning of activity in patients enrolled within SAP302 and was well tolerated during the study.
AcelRx Pharmaceuticals co-founder and chief medical officer Dr Pamela Palmer said: "The Department of Defence has provided us with development funding for ARX-04 and 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.
"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."
The initial Phase III SAP301 ambulatory surgery study of ARX-04 has also exhibited positive results in treating trauma or injury related, moderate-to-severe acute pain.
