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Article: AcelRx Announces Successful Completion of End-of-Phase 2 Meeting on ARX-01, Sufentanil NanoTab PCA System for Post-Operative Pain Management.(Clinical report)
- Article from:
- Blood Weekly
- Article date:
- November 12, 2009
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AcelRx Pharmaceuticals, Inc. announced that it has successfully completed an End-of-Phase 2 meeting with the FDA for ARX-01, a drug/device combination product based on the company's proprietary NanoTab™ dosage form, which enables delivery of sufentanil by the non-invasive oral transmucosal (sublingual) route. ARX-01 offers a non-invasive alternative to intravenous patient-controlled analgesia (IV PCA) for the management of acute post-operative pain in the hospital setting. The FDA reviewed a package based on positive Phase 2 clinical study results from three Phase 2 trials which demonstrated the functionality of the ARX-01 device and the safety and efficacy of ...