FDA Commissioner on approval of Dsuvia (sufentanil sublingual).

FDA Commissioner Scott Gottlieb, M.D.,statement on the agency�s approval of Dsuvia :"The crisis of opioid addiction is an issue of great concern for our nation. Addressing it is a public health priority for the FDA. The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs of patients and physicians managing pain. As part of these considerations, there�s been an important and robust public debate leading up to the regulatory decision on Dsuvia that merits a response. I want to take this opportunity to address some of the concerns that were raised, and more broadly, how I believe the FDA should consider the approval of new opioid pain medications that can help fill targeted medical needs. Looking beyond this particular drug approval, 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. As we look at the public health implications of each new approval, we should evaluate whether we need to take additional steps to systematically consider new opioids relative to the comparative benefit and risks of other opioids already on the market. We should consider whether we could do more in weighing approvals to ensure that new opioids are sufficiently better than existing drugs to justify their addition to the market in the context of the current crisis of abuse. 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. (abbreviated)