FDA Commissioner: ‘very tight restrictions’ on Dsuvia distribution, use

FDA Commissioner Scott Gottlieb issued a statement on the agency’s approval of Dsuvia, stating in part: “In this particular case, Dsuvia is a sublingual (under the tongue) formulation of sufentanil that’s delivered through a disposable, pre-filled, single-dose applicator. The medicine is restricted to use in certified medically-supervised health care settings – such as hospitals, surgical centers and emergency departments – for administration by a health care professional. Dsuvia, which was previously approved by the European Medicines Agency in July under the brand name Dzuveo, has some unique features in that 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 (DoD) 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. The involvement and needs of the DoD in treating soldiers on the battlefield were discussed by the advisory committee. There are very tight restrictions being placed on the distribution and use of this product. We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia, including requiring a Risk Evaluation and Mitigation Strategy (REMS) to accompany this drug. The REMS reflects the potential risks associated with this product and will tightly control its distribution and use. Importantly, the distribution system will restrict Dsuvia’s use to certified medically-supervised health care settings, an important step to help prevent misuse and abuse of Dsuvia. 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. But underlying the debate surrounding this approval is a broader issue that must be addressed head on: why do we need an oral formulation of sufentanil – a more potent form of fentanyl that’s been approved for intravenous and epidural use in the U.S. since 1984 – on the market? […] Currently, in applying our statute and regulations, we generally consider each new drug approval – and each new opioid drug approval – largely on its own merits. As part of our review, we ask whether the individual drug meets the standard for safety and effectiveness, and whether additional controls are needed to ensure safe use of that specific drug. But opioids are a unique class of medicines… I recognize that the debate goes beyond the characteristics of this particular product or the actions that we’re taking to mitigate this drug’s risks and preserve its differentiated benefits. 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…As a physician and regulator, I won’t bypass legitimate questions and concerns related to our role in addressing the opioid crisis.”

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