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March 4, 2013
18:03 EDTACRXAcelRx reports primary endpoint achieved in Sufentanil NanoTab PCA phase 3 trial
AcelRx Pharmaceuticals announced top-line data results demonstrating that the first of two pivotal placebo-controlled Phase 3 studies for its investigational sublingual Sufentanil NanoTab PCA System met its primary endpoint. Adverse events reported in the study were generally mild or moderate in nature and similar in both placebo and treatment groups. "These favorable results enable AcelRx to continue moving forward towards submission of a New Drug Application for the Sufentanil NanoTab PCA System in the third quarter of this year. In the weeks ahead, our team will work with the FDA to complete a pre-NDA meeting in support of this goal," said AcelRx CEO Richard King.
News For ACRX From The Last 14 Days
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November 13, 2014
07:08 EDTACRXAcelRx to present positive efficacy results in Phase 3 trial of Zalviso
AcelRx Pharmaceuticals will present safety and efficacy data from a Phase 3 pivotal trial evaluating the Zalviso sufentanil sublingual tablet system for the treatment of moderate-to-severe acute pain following joint replacement surgery at the American Society of Regional Anesthesia and Pain Medicine 13th Annual Pain Medicine Meeting on November 13th to November 16th in San Francisco. Data from the sublingual sufentanil tablet system development program highlights efficacy across various demographic populations

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