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February 19, 2013
07:34 EDTACRXAcelRx says Phase 3 trials continue to progress
AcelRx Pharmaceuticals announced continuing progress on its two remaining Phase 3 trials of the Sufentanil NanoTab PCA System being studied in post-operative pain. The first of those studies in patients after major abdominal surgery completed the last patient earlier this quarter, and is expected to provide data later this quarter. The second study, in patients after major orthopedic surgery, continues to enroll patients, with the last patient expected to enroll around the end of the first quarter of 2013, and data expected in the second quarter.  A New Drug Application submission for the NanoTab System remains on track for the third quarter of 2013.  In addition, a Phase 2 clinical trial with ARX-04, a sufentanil formulation for the treatment of moderate-to-severe acute pain, has completed dosing and results from this study are expected to be available in the second quarter of 2013, the company said.
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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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