General Information

Dsuvia (sufentanil) is an opioid agonist.

Dsuvia is specifically indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Dsuvia is supplied as a sublingual tablet. The recommended dosage of is 30 mcg sublingually as needed with a minimum of 1 hour between doses. Do not exceed 12 tablets in 24 hours. The maximum cumulative daily dose of sufentanil is 360 mcg or 12 tablets (12 tablets x 30 mcg/dose).

Clinical Results

FDA Approval

The FDA approval of Dsuvia was based on one randomized, double-blind, placebo-controlled trial which enrolled 161 patients (age 18 to 69 years) with acute postoperative pain (pain intensity of ≥ 4 on a 0-10 numeric rating scale) after abdominal surgery (studied up to 48 hours). Patients were dosed with Dsuvia 30 mcg or placebo as needed with a minimum of 60 minutes between doses. Morphine sulfate 1 mg IV was available as rescue medication. Patients using Dsuvia had a statistically significantly greater SPID12 than patients using placebo. Approximately 22% of patients in the Dsuvia group and 65% of patients in the placebo group took rescue medication within the first 12 hours of the treatment phase.

Side Effects

Adverse effects associated with the use of Dsuvia may include, but are not limited to, the following:

nausea

headache

vomiting

dizziness

hypotension

Dsuvia is supplied under the FDA-approved Risk Evaluation and Mitigation Strategies (REMS) program. Dsuvia will not be available in retail pharmacies or for outpatient use. Dsuvia will only be distributed to health care settings certified in the Dsuvia REMS program following attestation by an authorized representative that the healthcare setting will comply with appropriate dispensing and use restrictions of Dsuvia. As part of the REMS program, AcelRx will monitor distribution and audit wholesalers' data, evaluate proper usage within the healthcare settings and monitor for any diversion and abuse. Additionally, AcelRx will de-certify healthcare settings that are non-compliant with the REMS program.

Mechanism of Action

Dsuvia (sufentanil) is an opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principle therapeutic action of sufentanil is analgesia and sedation, thought to be mediated through opioid-specific receptors throughout the CNS. Like all full opioid agonists, there is no ceiling effect to analgesia.