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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.
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July 24, 2015
08:34 EDTACRXAcelRx's Zalviso recommended for marketing authorization by Europe's CHMP
AcelRx Pharmaceuticals announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, has adopted a positive opinion for Zalviso. The opinion, while not binding, recommends marketing authorization for Zalviso for the management of acute moderate-to-severe post-operative pain in adult patients. Zalviso is an investigational drug-device combination product designed to deliver a sublingual formulation of sufentanil 15 mcg via a proprietary pre-programmed, non-invasive, patient-controlled device. The positive opinion by the CHMP will next be reviewed by the European Commission for central marketing authorization in the European Union. If approved, Grunenthal expects to launch Zalviso beginning in 1H16. In addition, AcelRx would be eligible to receive a $15M milestone payment from AcelRx's licensee in Europe, Grunenthal, upon approval. AcelRx had previously received CE Mark approval of the Zalviso device and ISO certification of its quality management system issued by the British Standards Institution.

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