AcelRx 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.
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AcelRx reports Q4 adjusted EPS (18c), consensus (17c) Reports Q4 revenue $27.6M, may not compare to consensus $4.93M. During the fourth quarter of 2013, AcelRx received a $30M upfront payment from Grunenthal GmbH associated with the Zalviso commercialization agreement in the EU and Australia, of which $27.4M was recognized as revenue in the quarter.