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AcelRx Pharmaceuticals Presents ARX-04 Dose-Finding Phase 2 Study Data at Anesthesia Medical Conference
Date:12/13/2013

REDWOOD CITY, Calif., Dec. 13, 2013 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today presented additional detail from the Phase 2 dose-finding study of ARX-04, an investigational single-dose sublingual sufentanil NanoTab for moderate-to-severe acute pain, for which topline results were reported in April 2013. Patients treated with the 30 mcg dose of sufentanil showed a rapid onset of action with a statistically significant beneficial difference in pain relief (p<0.001) and pain intensity (p<0.01) seen at 30 minutes after dosing compared to placebo.  Dosing averaged every 2.4 hours over the duration of the 12-hour study.  In addition, patient global assessment of the 30 mcg dose at 12 hours was superior to placebo (p=0.002) with 43.6% vs. 5.0% of the patients responding good or excellent for overall pain control. The 20 mcg dose was not significant for either endpoint.  This study was funded by a grant from the U.S. Army Medical Research and Materiel Command. These results are being presented at the 67th Annual PostGraduate Assembly in Anesthesia being held in New York City.  

"These additional analyses of data from our Phase 2 study demonstrate a rapid onset of action and a sustained strong analgesic effect for ARX-04 (30 mcg), a non-invasive, healthcare provider-administered analgesic product candidate for the short-term treatment of moderate-to-severe acute pain where intravenous access may not be desirable or readily available," stated Dr. Pamela Palmer, Chief Medical Officer, AcelRx Pharmaceuticals. "These data will be reviewed in our End-of-Phase 2 meeting with the FDA later th
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SOURCE AcelRx Pharmaceuticals, Inc.
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