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FDA Quietly releases Dsuvia

November 5, 2018

On Friday, November 2, 2018, the Food and Drug Administration (FDA) approved a new Synthetic Opioid named Dsuvia that is being made by AcelRx Pharmaceuticals. Dsuvia is a tablet form of Sufentanil that is 10 times stronger than Fentanyl and 1000 times stronger than Morphine. Sufentanil has been used since the 1980s intravenously and in epidurals.


The FDA Advisory Committee recommended the release of Dsuvia by a 10-3 vote. Afterward, the chairman of the panel, Dr. Raeford Brown, wrote a letter to top FDA officials expressing deep concern. In the letter, Dr. Brown described Dsuvia as "an extremely divertible drug." Dr Brown also stated, "I predict that we will encounter diversion, abuse, and death within the early months of its availability on the market." Dr. Brown is an Anesthesiology Professor at the University of Kentucky.


FDA Commissioner, Dr. Scott Gottlieb, released a lengthy statement defending the agency's decision. In the statement, Dr. Gottlieb mentioned that Dsuvia's only permitted use will be I hospitals, surgical centers, and other medically supervised setting. The medication is delivered through a "pre-filled, single-dose applicator. The medication is to be used particularly for soldiers wounded in combat that do not a access to intravenous painkillers. Dsuvia will not be dispensed to patients for home use or available at retail pharmacies.


According to Vince Angotti, the Chief Executive of AcelRx, the company would diligently follow a safety program known as a risk evaluation and mitigation strategy.  The safety program includes monitoring the distribution of the drug, auditing wholesalers' data, evaluating whether hospitals and other health care providers are using the drug properly, and monitoring for any diversion or abuse.


SOURCE: New York Times

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