AcelRx Pharmaceuticals, Inc.(ACRX), Tuesday said a late-stage study of its investigational sublingual Sufentanil NanoTab PCA System (NanoTab System) reached primary endpoint. Results showed that patients receiving Sufentanil NanoTab after major orthopedic surgery, particularly knee or hip replacement, experienced substantial reduction in pain.
The study evaluated control of pain intensity compared to baseline during the 48-hour study period following surgery, using the FDA-requested primary endpoint of Summed Pain Intensity Difference to baseline (SPID-48).
Richard King, president and CEO of the company said, "...We remain on track for a third quarter 2013 NDA submission for the NanoTab System, a product which, if approved, will present AcelRx with an opportunity to fundamentally redefine the management of post-operative pain for tens of millions of patients both in the U.S. and around the world."
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