AcelRx announces top-line data from Sufentanil NanoTab PCA System Phase 3 trial

Published on December 15, 2012 at 1:36 AM · No Comments

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 that top-line data from its previously announced open-label, active-comparator study of its lead product candidate, the Sufentanil NanoTab PCA System, will be featured in poster presentations to be held at the 66th annual New York State Society of Anesthesiologists PostGraduate Assembly meeting in New York City to be held December 14-18, 2012.  The poster is authored by Dr. Timothy Melson of Helen Keller Hospital, Sheffield, AL, Dr. Alparslan Turan of The Cleveland Clinic, Cleveland, OH, and Dr. Pamela Palmer of University of California, San Francisco, and Chief Medical Officer of AcelRx Pharmaceuticals and will be presented on Sunday, December 16, 2012 from 11:00 AM to 1:00 PM at the New York Marriott Marquis.

Top-line results of the Phase 3 clinical trial demonstrate that the Sufentanil NanoTab PCA System was non-inferior (p<0.001) to intravenous (IV) patient-controlled analgesia (PCA) with morphine for the primary endpoint of Patient Global Assessment (PGA) of method of pain control over the 48-hour study period as determined by the combined percentage of patients with PGA ratings of "good" or "excellent" (78.5% vs. 66.1% respectively). The assessment of non-inferiority is based on a lower limit of -15% for the 95% confidence interval (CI) around the difference between these percentages. Because the 95% CI was +3.2% to +21.6% for the 48-hour PGA, a statistical analysis for superiority could be performed, which demonstrated that for this study, the NanoTab System was statistically superior to IV PCA morphine for the PGA endpoint (p=0.009). This statistically superior PGA was also seen at the 24 hour and 72 hour time points. Additionally, the percentage of patients rating the NanoTab System as "Excellent" was higher than those rating IV PCA morphine as excellent (42.9% vs. 30.6%, p=0.016). Similar percentages of NanoTab System-treated and IV PCA morphine-treated patients dropped out of the study prematurely due to lack of efficacy (7.3% vs. 8.3% respectively) or due to an adverse event (7.9% vs. 11.1% respectively).

Nurses setting up the different treatments for use and managing patients in the study reported greater Overall Satisfaction (3.93 vs. 3.32 out of 5, p<0.001) and Overall Ease of Care (4.26 vs. 3.82, p=0.018) with the Sufentanil NanoTab PCA System compared to IV PCA morphine. Likewise, patients in the study reported they had greater Overall Satisfaction (4.15 vs. 3.83 out of 5, p=0.003) and greater Overall Ease of Care (4.45 vs. 4.07, p<0.001) with the NanoTab System compared to IV PCA morphine.

"We are delighted to have the opportunity to present this important data at the prestigious PostGraduate Assembly meeting," commented Pamela Palmer MD, PhD, Chief Medical Officer and AcelRx co-founder.  "These first data from our Phase 3 program for the Sufentanil NanoTab PCA System demonstrate superiority over IV PCA morphine for both primary and secondary endpoints.  We look forward to the completion of our two remaining Phase 3 studies, which we expect to deliver in the first quarter of 2013," added Dr. Palmer.

Source:

AcelRx Pharmaceuticals, Inc.

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