Drugs

FDA Asked to Explain Dsuvia Approval

David McFarland

— 2 min read
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Sen. Edward Markey (D-MA) and Rep. Diana DeGette (D-CO) have written to FDA commissioner Scott Gottlieb expressing their concern with agency approval of AcelRx’ Dsuvia (sufentanil sublingual tablets) that they say is 10 times more potent than fentanyl and 1,000 times more powerful than morphine. “While we appreciate FDA’s intent to ensure Dsuvia is administered appropriately,” the letter says, “we remain concerned that Dsuvia’s specific properties also make the product highly divertible. Sufentanil has been known for decades to be diverted in its current intravenous form, and whether administered intravenously or sublingually, it can deliver a potency that has been known to be lethal in small dosages.”

The two lawmakers also note that the Dsuvia application was recommended for approval by the Anesthetic and Analgesic Drug Product Advisory Committee at a meeting at which the chairman, who had expressed serious concerns about the drug’s safety and efficacy, was not present. The chairman, Dr. Raeford Brown, has since raised “troubling questions about the FDA approval process, including the allegation that FDA disinvited certain members of the Drug Safety and Risk Management Advisory Committee … in order to make approval more likely,” the letter says. It also says Brown has raised concerns about Dsuvia, including questioning the FDA rationale for approving the drug based on its purported military applications.

Markey and DeGette ask FDA to produce all documents: 

  •          the agency relied on to conclude that Dsuvia “fills a specific and important, but limited, unmet medical need in treating our nation’s soldiers on the battlefield”;
  •          that relate to, describe, or summarize, or memorialize any communication between FDA and the U.S. Army Medical Research and Materiel Command about FDA consideration of the drug application;
  •          that relate to, describe, summarize, or memorialize any communication from FDA to any member of the Drug Safety and Risk Management Advisory Committee disinviting them from the 10/12/18 Anesthetic and Analgesic Drug Products Advisory Committee meeting concerning Dsuvia;
  •          concerning FDA’s decision to disinvite members of the Drug Safety and Risk Management Advisory Committee from the 10/12/18 Anesthetic and Analgesic Drug Products Advisory Committee meeting; and
  •          concerning FDA’s decision not to empanel the full Drug Safety and Risk Management Advisory Committee for consideration of the Dsuvia application.

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