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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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October 9, 2015
20:11 EDTACRXAcelRx management to meet with Roth Capital
Meeting to be held in San Francisco on October 15 hosted by Roth Capital.
October 8, 2015
07:02 EDTACRXAcelRx provides update on Zalviso
AcelRx provided a regulatory update on Zalviso intended for the management of moderate-to-severe acute pain in adult patients in the hospital setting. The company has received formal minutes of the telephonic meeting held in early September 2015, with the Division of Anesthesia, Analgesia, and Addiction Products of the FDA. As reflected in the minutes, the Division restated at the meeting a request for clinical data to complement other data AcelRx has developed to assess the overall performance of the Zalviso device. The company is planning to submit a protocol to the Division for a clinical study in post-operative patients designed to evaluate the effectiveness of changes made to enhance product performance. AcelRx expects to be ready to initiate the study in the first quarter of 2016, and likely will await comments on the protocol from the Division. The company will be prepared to work with the FDA to facilitate the timely study initiation.
October 6, 2015
07:01 EDTACRXAcelRx announces initiation of clinical study of ARX-04 in ER patients
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October 5, 2015
09:08 EDTACRXAcelRx price target raised to $10.50 from $8.50 at Roth Capital
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October 1, 2015
06:09 EDTACRXAcelRx to host analyst and investor day
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