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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. “As a single-dose, non-invasive medication with a rapid reduction in pain intensity, Dsuvia represents an important alternative for healthcare providers to offer patients for acute pain management.”
“The approval of Dsuvia, which was developed in collaboration with the Department of Defense, underscores our commitment to provide innovative therapies for use in medically supervised settings,” said Vince Angotti, Chief Executive Officer, AcelRx. “We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings. We are committed to the safe and effective administration of Dsuvia through diligent adherence to our FDA-approved Risk Evaluation and Mitigation Strategies program.”
The efficacy and safety of Dsuvia were evaluated in 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.
In controlled and uncontrolled studies, the safety of Dsuvia was evaluated in a total of 646 patients with moderate-to-severe postoperative pain or pain due to trauma which required opioid analgesia. The most frequently reported adverse reactions ≥ 2% in the randomized, placebo-controlled trial were nausea, headache, vomiting, dizziness, and hypotension. The Dsuvia clinical program builds upon the established safety and efficacy of the reference product, sufentanil citrate injection, which has been in commercial use for over three decades.
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 Risk Evaluation and Mitigation Strategy (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.
Dsuvia, known as Dzuveo outside the United States, approved by the FDA in November 2018, is 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 was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with IV administration.
Dsuvia is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic currently marketed for intravenous (IV) and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The European Medicines Agency (EMA) approved DZUVEO for marketing in Europe in June 2018.