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FDA, AcelRx Announce Approval of Dsuvia, with Disclaimers

November 7, 2018
The sufentanil tablet will have heavy limitations on usage

A PPM Brief

AcelRx Pharmaceuticals (Redwood City, CA) has announced1 FDA approval of Dsuvia (30mcg sufentanil tablet), indicated for the management of acute pain in adults and administered in certified healthcare settings, such as hospitals, surgical centers, and emergency departments. DSUVIA is a single-dose, pre-filled applicator for sublingual administration. The single-strength tablet and its single-unit packaging are designed to mitigate the possibility of dosing errors, misuse, and diversion.

A randomized, double-blind, placebo-controlled trial of Dsuvia enrolled 161 patients (age 18 to 69 years) with acute postoperative pain after abdominal surgery (studied up to 48 hours), which included dosing patients with Dsuvia 30 mcg or placebo as needed with a minimum of 60 minutes between the administration of doses. Patients using Dsuvia showed a statistically significantly greater summed pain intensity difference over a 12-hour study period (SPID12) than patients using placebo. Approximately 22% of patients in the Dsuvia group and 65% of patients in the placebo group took rescue medication (morphine sulfate 1 mg IV) within the first 12 hours of the treatment phase.

(Source: 123RF)

"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 David Leiman, MD, clinical assistant professor of surgery at the University of Texas at Houston, in an AcelRx press release. "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."

With questions surrounding the medication, which is far more potent than fentanyl and approaching the market at a time when the opioid crisis is unresolved, FDA Commissioner Scott Gottlieb, MD, released an approval statement2 on Dsuvia—an action not often taken. He noted:

… 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. For this reason, the Department of Defense worked closely with the sponsor on the development of this new medicine. This opioid formulation, along with Dsuvia’s unique delivery device, was a priority medical product for the Pentagon because it fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield.”

Gottlieb also mentioned the limitations associated with Dsuvia in an FDA press release about the approval, saying that the opioid:

…can’t be dispensed to patients for home use and should not be used for more than 72 hours. Dsuvia is also to be reserved for use in patients for whom alternative pain treatment options have not been tolerated, or are not expected to be tolerated, where existing treatment options have not provided adequate analgesia, or where these alternatives are not expected to provide adequate analgesia.”

Further acknowledging the controversial decision surrounding the FDA’s opioid policies and future approvals, Dr. Gottlieb offered some potential policy changes going forward. “I believe that we should consider whether we should be doing more to evaluate each candidate opioid, not just as an independent review decision, but rather also to consider each novel opioid drug in the context of the overall therapeutic armamentarium that’s available to patients and providers,” he said. He went on to add that, “We won’t sidestep what I believe is the real underlying source of discontent among the critics of this approval—the question of whether or not America needs another powerful opioid while in the throes of a massive crisis of addiction. It’s an important question that has surfaced in past approval decisions and will come up again in the future.”

Commercial launch of Dsuvia is expected in Q1 of 2019.

Last updated on: November 7, 2018
Continue Reading:
A Brief History of the FDA’s Role in the Ongoing Effort to Ensure Safe Opioid Use
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