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December 14, 2012
07:31 EDTACRXAcelRx announces top-line data from Phase 3 study of Sufentanil NanoTab
AcelRx Pharmaceuticals announced top-line data from its previously announced open-label, active-comparator study of its lead product candidate, the Sufentanil NanoTab PCA System. Top-line results of the Phase 3 clinical trial demonstrate that the Sufentanil NanoTab PCA System was non-inferior to intravenous patient-controlled analgesia with morphine for the primary endpoint of Patient Global Assessment of method of pain control over the 48-hour study period as determined by the combined percentage of patients with PGA ratings of "good" or "excellent".
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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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