AcelRX Submits NDA for Patient-Activated Analgesic System
AcelRx announced that it has submitted a New Drug Application (NDA) to the FDA for Zalviso (sufentanil sublingual microtablet system) for the management of moderate-to-severe acute pain in adult patients in the hospital setting. Zalviso is a pre-programmed, patient-activated, non-invasive, handheld analgesic system, which delivers the dose as needed for pain control, subject to a 20-minute lockout period between doses.
The NDA submission was based on data from a Phase 3 registration program that included two double-blind randomized placebo-controlled clinical trials, one conducted in patients following major abdominal surgery, the other in patients following major joint replacement surgery.
In each of these trials, patients treated with Zalviso to manage their post-surgical pain reported a greater sum of the pain intensity difference to baseline over 48 hours (SPID-48) compared to placebo-treated patients (P=0.001 and P<0.001, respectively).
Additionally, a Phase 3 open-label active-comparator trial was conducted in patients following either major abdominal or orthopedic surgery, comparing Zalviso to the current standard of care, intravenous patient-controlled analgesia (IV PCA) with morphine. Zalviso successfully achieved the primary efficacy endpoints for this study.
Results reported for this study included:
- Zalviso was non-inferior (P<0.001) to IV PCA morphine based on the primary endpoint of Patient Global Assessment of method of pain control comparison over the 48-hour trial period (PGA48) as determined by the combined percentage of patients with PGA ratings of "good" or "excellent".
- A secondary comparison of the primary endpoint demonstrated that Zalviso was statistically superior to IV PCA morphine for the PGA48 endpoint (P=0.007).
- Statistically superior and non-inferior PGA comparisons for Zalviso compared to IV PCA morphine were also seen at the 24-hour and 72-hour time points.