FDA to Review Zalviso PCA System for Acute Pain
The FDA has accepted the New Drug Application (NDA) for Zalviso (sufentanil sublingual microtablet system; AcelRx) 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 trials – one evaluating patients following major abdominal surgery, and the other evaluating patients following major joint replacement surgery.
The submission also includes data from a Phase 3 open-label active-comparator trial conducted in patients following either major abdominal or orthopedic surgery.
For more information call (650) 216-3500 or visit AcelRx.com.