FDA approves Dsuvia for acute pain.- AcelRx Pharmaceuticals.

AcelRx Pharmaceuticals announced today the approval of Dsuvia (sufentanil nanotab) by the FDA, indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments. Dsuvia is a 30 microgra sufentanil tablet in a single-dose, pre-filled applicator for sublingual administration.

In a randomized, double-blind, placebo-controlled clinical study, Dsuvia demonstrated a statistically greater summed pain intensity difference from baseline over the first 12 hours of the study (SPID12) compared to placebo. The pain intensity difference from baseline was superior to that of the placebo group within 15 minutes and median meaningful pain relief occurred following a single dose. The single-strength tablet and single-unit packaging are designed to mitigate the possibility of dosing errors, misuse and diversion. The sublingual administration makes Dsuvia an option for patients with nothing by mouth (NPO) status and patients with difficult IV access (obese, elderly, burn or needle-phobic patients). Avoiding an IV has the potential to offer efficiency improvements in healthcare settings and improve patient experience.

Comment: Dsuvia, which was previously approved by the European Medicines Agency in July under the brand name Dzuveo, has some unique features in that the drug is delivered in a stable form that makes it ideally suited for certain special circumstances where patients may not be able to swallow oral medication, and where access to intravenous pain relief is not possible. This includes potential uses on the battlefield. Launch is expected in the first quarter of 2019.