AcelRx announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Dsuvia (formerly ARX-04; sufentanil sublingual tablet) for the treatment of moderate-to-severe acute pain in a medically supervised setting.
The NDA submission for Dsuvia was based on data from two randomized, double-blind, placebo-controlled Phase 3 trials (SAP301 and SAP202) and two open-label Phase 3 safety and efficacy studies (SAP302 and SAP303) in patients with moderate-to-severe acute pain. Additional safety results from the Zalviso (sufentanil sublingual tablet system; AcelRx) clinical program also supported the NDA.
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of October 12, 2017 to make a decision on the NDA. The agency also communicated its plan to hold an Advisory Committee meeting to review the application.
Dsuvia, formerly ARX-04, is an investigational, sublingual formulation of 30mcg sufentanil in a disposable, pre-filled, single-dose applicator (SDA).
For more information call (650) 216–3500 or visit AcelRx.com.