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Acelrx builds case for pain drug approval with new phase III data

By Michael Fitzhugh
Staff Writer

Monday, August 15, 2016

Acelrx Pharmaceuticals Inc. moved its sublingual sufentanil candidate ARX-04 (sufentanil sublingual tablet, 30 mcg) closer to an anticipated FDA new drug application (NDA) filing this year, announcing top-line results of a small phase III results that showed emergency room (ER) patients realizing an average 35 percent drop in pain intensity one hour after treatment. The trial bolstered safety data for inclusion in the NDA while also ruling out any cognitive impairment issues, chief medical officer and co-founder Pamela Palmer told BioWorld Today.

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