AcelRx Pharma (ACRX) Says ARX-04 Phase 3 Met Primary Endpoint in Trauma/Injury Pain Reduction

August 15, 2016 7:08 AM EDT

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AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) reported topline results from the single-arm, open-label Phase 3 SAP302 trial (NCT02447848), which assessed ARX-04 (sufentanil sublingual tablet, 30 mcg) in patients who presented to the emergency room with moderate-to-severe acute pain associated with trauma or injury. Overall, the 76 adults treated with ARX-04 in this study experienced a mean pain intensity difference to baseline (PID) of 2.9 from a baseline of 8.1, or 35%, on a 0 – 10 numeric rating scale at 60 minutes.

SAP302 enrolled patients in two cohorts. The initial phase enrolled 40 adults who were administered a single dose of ARX-04; and an extension phase enrolled 36 adults who were eligible to receive up to four doses of ARX-04, given hourly as needed for pain. Interim results from the first cohort were reported in February 2016, and showed that patients treated with a single dose of ARX-04 experienced a mean pain intensity decrease from baseline of 2.7 at 60 minutes. Patients in the second cohort reported a mean pain intensity decrease from baseline of 3.1 on the 0 – 10 pain intensity scale at 60 minutes. Of these 36 patients, seven received a second dose of ARX-04, and two received a third dose. For 75% of patients in the second cohort, a single dose of ARX‑04 was sufficient for pain relief and only 8% of patients received morphine in addition to ARX-04.

In addition, ARX-04 demonstrated a predicted onset of activity in patients enrolled in SAP302. Patients reported a mean pain intensity decrease of 1.1 compared to baseline 15 minutes following first administration of ARX-04, and a decrease of 1.9 after 30 minutes.

Overall ARX-04 was well tolerated in this study, with 79% of patients reporting no adverse events. The most common adverse events reported in the study occurred with single-digit rates - the most common being nausea (9%), somnolence (5%) and vomiting (4%). All these events were rated as mild with the exception of one event of moderate nausea. Drug-induced cognitive impairment was not seen with ARX-04 in this study, as assessed using the validated Six-Item Screener.

"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," explained Dr. Pamela Palmer, co-founder and chief medical officer of AcelRx Pharmaceuticals. "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."

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