AcelRx announced that the Food and Drug Administration (FDA) has approved Dsuvia (sufentanil) sublingual tablets 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. It is not intended for use beyond 72 hours.
The sublingual formulation of sufentanil offers a new treatment option for patients with nothing by mouth (NPO) status and patients with difficult IV access (eg, obese, burn, elderly, needle-phobic patients) to manage acute pain. The single-unit packaging and single-strength sublingual tablets are intended to mitigate the possibility of dosing errors, misuse, and diversion. “Managing acute pain is critical to a patient’s recovery process, especially in the postoperative setting, but current oral and IV opioid analgesics can be slow-acting and challenging to dose and administer, which in turn can limit optimal pain relief and even be dangerous to patients,” said Dr. David Leiman, Clinical Assistant Professor of Surgery, University of Texas at Houston and Director of HD Research.
Dsuvia was evaluated in a randomized, double-blind, placebo-controlled study (N=161) involving patients with acute postoperative pain after abdominal surgery (studied up to 48hrs). Study patients were randomized to Dsuvia 30mcg or placebo as needed with dosing at least 60mins apart; IV morphine sulfate was available as rescue medication.
The data showed a statistically greater summed pain intensity difference from baseline over the first 12 hours of the study (SPID12) compared with placebo. The difference in pain intensity from baseline was superior to that of the placebo group within 15 minutes. Also, a smaller proportion of patients in the Dsuvia group took rescue medication within the first 12 hours of the treatment phase, as compared with the placebo group (22% vs 65%). Regarding safety, the most commonly reported adverse reactions were nausea, headache, vomiting, dizziness, and hypotension.
In a statement, the FDA’s Commissioner Scott Gottlieb, MD, said, “The FDA will continue to carefully monitor the implementation of the REMS associated with Dsuvia and compliance with its requirements, and we’ll work to quickly make regulatory adjustments if problems arise […] I believe that the unique aspects of Dsuvia, including those that make this drug a high priority for the Pentagon, differentiate this new formulation of sufentanil from other sufentanil products in a way that is consistent with population-based considerations for how it fits into the overall drug armamentarium.”
Dsuvia, a Schedule II substance, will be available as 30mcg strength sublingual tablets in a single-dose, pre-filled applicator for administration by a healthcare professional only in certified medically supervised settings. Distribution is expected in the first quarter of 2019 only to healthcare settings certified in the Dsuvia Risk Evaluation Mitigation Strategy (REMS) program. Dsuvia will not be available in retail pharmacies or for outpatient use.
For more information call (650) 216-3500 or visit AcelRx.com.