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AcelRx Pharmaceuticals Reports First Quarter 2012 Financial Results
Date:5/8/2012

he treatment of acute post-operative pain in adults immediately following major abdominal or orthopedic surgery.

General and administrative expenses were $2.1 million for the quarter ended March 31, 2012, compared with $1.6 million for the quarter ended March 31, 2011.  This increase resulted primarily from expenses associated with market research and patent prosecution efforts as well as personnel related expenses, including stock-based compensation, and expenses associated with being a public company.

As of March 31, 2012, AcelRx had cash, cash equivalents and investments of $27.6 million, compared to $35.8 million at December 31, 2011.

"With two of our three planned Phase 3 clinical studies actively enrolling, and with the initiation of the third Phase 3 clinical study planned for the third quarter of 2012, we are looking forward to seeing top-line data from all three Phase 3 clinical trials by late 2012 or early 2013," said Richard King, President and CEO of AcelRx.  Mr. King added, "Based on our dialog with FDA, data from these studies should support an NDA filing, expected in the middle of 2013."

Development Update

  • In March 2012, AcelRx initiated the first of three planned Phase 3 clinical trials, a double-blind, placebo-controlled efficacy and safety trial of adult patients with post-operative pain following open-abdominal surgery.  We expect top-line data for this trial in the second half of 2012.
  • In April 2012, AcelRx initiated a second Phase 3 clinical trial, an open-label active-comparator study comparing ARX-01 to the current standard of care, IV PCA with morphine, in patients with post-operative pain following open-abdominal surgery or major orthopedic surgery.  We expect top-line data for this trial in the second half of 2012.
  • In the third quarter of 2012, AcelRx plans to initiate our third planned Phase 3 clinical trial, a double-blind, placebo-controlled efficacy and
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  • SOURCE AcelRx Pharmaceuticals, Inc.
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