The FDA approved a potent new opioid despite serious doubts that have been raised about the drug’s safety and necessity by people concerned about the country’s opioid epidemic, including opposition from the chair of the FDA committee that recommended the drug's approval.
Dsuvia is a sublingual formulation (meaning it dissolves under the tongue) of the potent opioid sufentanil, a more potent form of fentanyl that has been approved for intravenous and epidural use in the U.S. since 1984, according to a November 2 press release from FDA Commissioner Scott Gottlieb, M.D., addressing the controversy surrounding the decision.
The drug comes in 30 mcg doses via a disposable, pre-filled, single-dose applicator. But it's only meant to be administered by medical professionals in health care settings (like hospitals), meaning it’s not something you can pick up at your local pharmacy with a prescription from your doctor.
Dsuvia is meant to be used only in patients who haven't responded to other pain medications.
“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,” Dr. Gottlieb says in his statement. According to him, the drug is best for patients whose pain isn't adequately treated with other drugs or those who can't tolerate those drugs.
He also points out Dsuvia's potential for military application, noting that the Department of Defense collaborated closely with AcelRx, the maker of Dsuvia. “The FDA has made it a high priority to make sure our soldiers have access to treatments that meet the unique needs of the battlefield, including when intravenous administration is not possible for the treatment of acute pain related to battlefield wounds,” he says.
However, critics argue that Dsuvia's potential value doesn't outweigh its risks.
“It has no unique place in the current armamentarium of analgesics,” Raeford Brown, M.D., chair of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC), the FDA body charged with evaluating such drugs, tells SELF. (Dr. Brown, who is also a professor of anesthesiology and pediatrics at the The University of Kentucky and The Kentucky Children’s Hospital and chair of the Section on Anesthesiology and Pain Medicine at The American Academy of Pediatrics, was not in attendance at the AADPAC's October vote due to prior commitments, but co-wrote a bold letter of opposition to the FDA’s decision with a group of health experts at the nonprofit consumer advocacy organization Public Citizen).
Dr. Brown questions how many patients are not able to be adequately treated by one of the 440 formulations currently available—including Abstral, a comparably strong drug designed to treat breakthrough pain associated with cancer that's also available in sublingual form—and therefore how dire the demand for more opioids really is.
“To think that we really need another [opioid] is a stretch,” Timothy Brennan, M.D., director of the Addiction Institute at Mount Sinai West and Mount Sinai St. Luke’s Hospitals and director of the Fellowship in Addiction Medicine Program at the Icahn School of Medicine Mount Sinai, tells SELF.
And in the context of the current opioid epidemic, experts worry that another potent drug like this could have real human costs. “We as a country are guzzling down opioids at profoundly greater rates than any other country, and to introduce another opioid in the midst of the American opioid crisis—it defies reason,” Dr. Brennan says. “Fentanyl and its analogues are being misused, being abused, and finding their way into the illicit opioid supply," he continues. "The fear as an addiction doctor is that this product will [do the same] and lead to people overdosing.”
The high potency of Dsuvia is especially concerning to him. “What worries me and I think many others throughout medicine about this product is that it’s so toxic—it’s so many times stronger than other conventional opioids like morphine.”
The FDA says it's instituting "very tight restrictions" to prevent the misuse and abuse of Dsuvia given the rampant opioid problem.
“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,” Dr. Gottlieb’s November 2 statement reads.
Per FDA requirements, AcelRx has put forth a Risk Evaluation and Mitigation Strategy (REMS) program to tackle these concerns. “It can’t be dispensed to patients for home use and should not be used for more than 72 hours. And it should only be administered by a health care provider using a single-dose applicator,” Dr. Gottlieb’s statement reads. “These measures to restrict the use of this product only within a supervised health care setting, and not for home use, are important steps to help prevent misuse and abuse of Dsuvia, as well reduce the potential for diversion.”
The FDA also notes that, like all opioids, Dsuvia will carry a boxed warning about both the serious potential side effects of the drug (including respiratory depression, coma, and death) and its potential for abuse. The FDA will also carefully monitor the implementation of the REMS and “work to quickly make regulatory adjustments if problems arise.”
But skeptics point out that similarly tight restrictions were placed on other opioids that are currently being abused, such as fentanyl. “Historically, the reality of the situation is [that] we haven’t been able to control any other opioid,” Dr. Brown says. “I don't have any confidence that were going to be any more successful with sufentanil,” Dr. Brennan adds.
The controversy surrounding this drug's approval is part of a larger problem the FDA—and the country—is currently facing.
“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," Dr. Gottlieb says in his statement. “It’s an important question that has surfaced in past approval decisions and will come up again in the future. As a public health agency, we have an obligation to address this question openly and directly.”
Dr. Gottlieb says that although the FDA evaluates each new drug based largely on its own merits, the agency is working to incorporate broader public health concerns like the opioid crisis. He notes that last month, Congress granted the FDA “novel and specific authorities” to regulate the opioid market by, among other things, imposing certain packaging requirements and requiring post-market studies on the efficacy of certain drugs.
But there's obviously still more to do. “We need to be thoughtful and spend our money developing non-opioid options, so people can get good, clinically significant acute pain control without the problems associated with opioids,” Dr. Brown says. “In order for us to not have a continuing opioid crisis in the U.S., we need to be thinking about how we can use fewer opioids, not more.”