AcelRx Pharmaceuticals Provides Clinical Tri... ( REDWOOD CITY Calif. Feb. 19 2013 ...)

AcelRx Pharmaceuticals Provides Clinical Trial Updates

Date:2/19/2013

REDWOOD CITY, Calif., Feb. 19, 2013 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today 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 (NDA) 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.

"We look forward to sharing the top-line results from our abdominal surgery pain study with our lead product candidate, the Sufentanil NanoTab PCA System, later this quarter and remain on track for an NDA submission later this year," said Richard King , president and chief executive officer of AcelRx.

Status of Ongoing Clinical Trials

The last patient has completed the Sufentanil NanoTab PCA System Phase 3 double-blind, placebo-controlled post-operative pain study conducted in patients following open abdominal surgery. The study, initiated in March 2012, enrolled 178 patients at 14 sites. T
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SOURCE AcelRx Pharmaceuticals, Inc.
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