(ChemotherapyAdvisor) – Sublingual opioid sufentanil NanoTab PCA (patient-controlled analgesia) is superior to intravenous PCA morphine for post-surgical acute pain management, according to an open-label, randomized phase 3 non-inferiority and efficacy study announced by AcelRx Pharmaceuticals.
A primary endpoint of non-inferiority using patient global assessments (PGA) of pain was met, company officials announced. The study enrolled 359 adult patients at 26 sites across the United States, randomizing patients 1:1 to receive either sufentanil (15 µg/dose) or morphine (1 mg/dose) for the control of acute post-operative pain at 24, 48, and 72 hours after major abdominal or orthopedic surgery.
At 48 hours, 78.5% of patients reported PGA ratings of “good” or “excellent” pain control with sufentanil, versus 66.1% of patients administered IV PCA morphine (P=0.009), the company reported. Similarly statistically-superior PGA ratings were found at 24 and 72 hours, though statistical details have not yet been announced for these time-points.
A greater percentage of patients rated sufentanil as “excellent” than rated morphine as “excellent” (42.9% vs. 30.6%; P=0.016), the company noted.
Nurses and patients “rated Sufentanil NanoTab PCA System higher for overall satisfaction and ease of care compared to IV PCA morphine,” stated a company announcement. Adverse event and study drop-out rates were not statistically different for sufentanil and morphine-arm participants.
“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,” said AcelRx President and CEO Richard King. “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.”
Additional information about the phase 3 clinical trials with the NanoTab System is available online at www.clinicaltrials.gov using the clinical trial identifiers NCT01660763, NCT01539642 and NCT01539538.