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FROM EARLIER: AcelRx Announces Primary Endpoint Met in Phase 3 Non-Inferiority Study of Sublingual Sufentanil NanoTab® PCA System vs. IV PCA Morphine for Post-Operative Pain

AcelRx Pharmaceuticals(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 top-line data showing that the open-label Phase 3 study of its investigational sublingual (under the tongue) Sufentanil NanoTab PCA (patient-controlled analgesia) System met its primary endpoint of non-inferiority in patient global assessment (PGA) with method of pain control in comparison to intravenous (IV) PCA with morphine. Additional analyses also showed that in this study the NanoTab System was statistically significantly superior to IV morphine for the PGA measurement. In addition, using validated assessment tools, nurses managing patients in the study and the patients themselves reported that they had significantly greater Overall Satisfaction with the NanoTab System compared to IV PCA morphine and significantly greater Overall Ease of Care with the NanoTab System compared to IV PCA morphine.

"With these impressive top-line results from this head-to-head clinical trial, we have successfully completed an important step towards our New Drug Application (NDA) submission and, dependent on completing the remaining Phase 3 trials and obtaining FDA approval, eventual commercialization of the Sufentanil NanoTab PCA System," commented Richard King, President and CEO, of AcelRx Pharmaceuticals, Inc. "Delivering patient-controlled analgesia in a non-invasive, pre-programmed system that provides powerful pain control while enhancing patient ease of care and satisfaction and nurse satisfaction compared to current invasive delivery systems will be a major advance for hospital care."

Utilizing a randomized, open-label, parallel-group design, this Phase 3 study enrolled 359 adult patients at 26 U.S. sites and compared efficacy and safety of AcelRx's investigational ARX-01 sublingual Sufentanil NanoTab PCA System (15 mcg/dose) to the commonly used IV PCA with morphine (1 mg/dose) for the treatment of acute post-operative pain immediately following major abdominal or orthopedic surgery. Patients were randomized 1:1 to treatment with the NanoTab System or IV PCA morphine and were treated for post-operative pain for a minimum of 48 hours and up to 72 hours.

Top-line results of the Phase 3 clinical trial demonstrate that the Sufentanil NanoTab PCA System was non-inferior (p<0.001) to IV PCA morphine for the primary endpoint of PGA 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 and therefore didn't cross the zero difference line, 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 timepoints. 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 that they had 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 that 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.

Posted-In: News FDA

 

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