AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, today reported encouraging interim efficacy and safety results of the ongoing single-arm, open-label Phase 3 study (SAP302) of ARX-04 for the treatment of adult patients who present in the emergency room with moderate-to-severe acute pain associated with trauma or injury. The primary endpoint of this initial single-dose phase of the study is the time-weighted summed pain intensity difference to baseline over the first hour, or SPID1. The 40 patients who have been enrolled and treated to date in this study experienced a substantial clinical reduction in pain intensity, resulting in a SPID1 value that is similar to previous studies of sublingual sufentanil in post-operative patients. Patients treated with one dose of ARX-04 experienced a mean decrease from ba
seline of 2.7 on a 0 – 10 numeric rating scale for pain intensity one hour after dosing. Adverse events were consistent with previous clinical studies, with the most frequent events, nausea and somnolence, each reported in two of the 40 patients. None of the participants to date have terminated the study early due to adverse events.
“The safety and efficacy profile we have observed in this Phase 3 ER study is consistent with previous trial results,” commented Dr. Pamela Palmer, co-founder and chief medical officer of AcelRx Pharmaceuticals. “In addition to its analgesic efficacy, we assessed the cognitive impact of ARX 04 on patients in this study. We conducted this analysis at the request of the United States Department of Defense, since drug-induced cognitive impairment on the battlefield is a particular concern. Using a well-known cognitive test, the Six-Item Screener, patients demonstrated no change in mean test scores before and after dosing.”
Dr. James Miner, the chief of emergency medicine at Hennepin County Medical Center in Minneapolis, MN and primary investigator of the ARX-04 studies, added, “In my clinical experience in a high-capacity emergency department, I believe a product with the ability to mitigate pain rapidly, without the practical and logistical impediment of starting an intravenous line, holds great potential for use in the ER. My experience with ARX-04 in this trial has been positive from both an efficacy and safety standpoint and I look forward to completing the trial and in the near future possibly having a new treatment option to offer my patients.”
The SAP302 study will continue to enroll patients, with a goal of enrolling up to 120 patients in total. The extension arm of the study will allow for multiple doses of ARX-04, given hourly as needed for pain, for up to 4 doses. The company expects to initiate the extension portion of the study by the end of the first quarter of 2016.
Source: AcelRx Pharmaceuticals, Inc.