Tuesday, 19 Mar 2019

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Controversial New Super Opioid Approved by FDA

Amidst a new DEA report demonstrating a record number of opioid overdose deaths (n-72,000 or ~ 200 deaths per day), the FDA has approved a newer and far more potent opioid than those that are currently being abused at alarming rates.  The new agent is named Dsuvia.

However, since its approval last week, advocacy groups and politicians have criticized the FDA’s approval of Dsuvia, a drug they believe will only add to the current crisis of opioid abuse. 

Dsuvia (sufentanil sublingual tablet 30 mcg) was approved on November 2nd and is indicated for the management of acute pain severe enough to require an opioid analgesic for adult patients in certified medically supervised healthcare settings. It is unique in being the first and only sufentanil sublingual tablet approved for acute pain in healthcare settings.

Dusuvia is the tablet form of sufentanil that use to be given sublingually. It's five to 10 times stronger than fentanyl, and 500 to 1000 times more powerful than morphine. 

FDA commissioner, Dr. Scott Gottlieb has issued a statement about this particular approval, noting "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.... 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."

The FDA has approved this drug with "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."

The manufacturer, AcelRx, estimates Dsuvia’s market potential to be approximately $1.1 billion in the United States alone. The U.S. launch is expected in the first quarter of 2019. 

Disclosures: 
The author has no conflicts of interest to disclose related to this subject

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