The approval is based on data from a multicenter trial in which patients were randomized 2:1 to receive either 30 mcg of the sufentanil sublingual tablet as needed, or placebo, with treatment limited up to 48 hours following the procedure.
Officials with the FDA have approved a new opioid, (Dsuvia, AcelRx Pharmaceuticals), sparking some controversy in the media that the opioid has potential for abuse. However, the approval indicates the opioid is to only be used in certified medically supervised health care settings, such as hospitals, surgical centers, and emergency departments.
Dsuvia is a 30 microgram (mcg) sufentanil tablet in a single-dose, pre-filled applicator for under the tongue (sublingual) administration by a health care professional only in certified medically supervised settings. The single-strength tablet and single-unit packaging are designed to mitigate the possibility of dosing errors, misuse and diversion.
According to a prepared statement from AcelRx, in a randomized, double-blind, placebo-controlled clinical study, which enrolled 161 patients, ages 18 to 69 years, the medication 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 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), according to the statement. Avoiding an IV has the potential to offer efficiency improvements in healthcare settings and improve patient experience. There are an estimated 92 million annual adult patient visits to medically supervised settings for moderate-to-severe acute pain. An estimated 51 million of these visits are to emergency departments (ED), with an estimated 18 million of these ED patients receiving an IV only for pain management.
News outlets have decried the approval and emphasized sufentanil’s effects as “500 times more powerful than morphine;” however, Pamela Palmer, MD, PhD, chief medical officer of AcelRx Pharmaceuticals, which developed the drug, explained in an interview with Pharmacy Times' sister publication, MD Magazine, that these overstatements are misguided.
“There are 2 key things to keep in mind,” Palmer said in the interview with MD Magazine®. “[Sufentanil sublingual tablet] is not for outpatient use. It is only going to be used in medically-supervised settings, which [will not] contribute to the outpatient abuse issue. In addition, potency, once it is dose-adjusted, is no longer a safety concern.”