- The Food and Drug Administration's approval of a powerful new opioid stirred up fierce opposition in some consumer and healthcare circles after it was announced Friday, continuing debate about the agency's role and responsibility in the opioid crisis.
- Leading the dissent was Raeford Brown, the chairman of an FDA advisory committee that reviewed AcelRx Pharmaceuticals' Dsuvia last month and ultimately recommended its approval in a 10-3 vote. "I predict that we will encounter diversion, abuse, and death within the early months of its availability on the market," Brown wrote in an Oct. 18 letter after missing the committee's Oct. 12 meeting.
- Along with the approval, Commissioner Scott Gottlieb released a statement of more than 2,200 words explaining the decision as well as how the agency will consider future opioid applicants. Gottlieb noted Dsuvia was "a priority medical product for the Pentagon" and the military's use "was carefully considered in this case."
Dsuvia (sufentanil) is an exceptionally powerful opioid, roughly 1,000 times stronger than morphine and more potent than fentanyl. While intravenous and epidural administrations of sufentanil have been FDA-approved for decades, Dsuvia's oral, under-the-tongue formulation was developed in collaboration with the Department of Defense.
The approval comes just a bit more than a year after President Donald Trump declared the opioid crisis a public health emergency. Drug overdose estimates from the Centers for Disease Control and Prevention hit record highs the past two years.
The FDA head directly acknowledged this backdrop in his explanation for Dusvia's approval.
"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," Gottlieb said in his written statement.
He also stated he believes FDA approval for opioids should come "within a broad public health context," one that acknowledges other opioids on the market, alternative therapeutic options, the ongoing epidemic and the risk for further abuse.
An opioid policy steering committee is developing new guidance documents to help the FDA "consider the benefits and risks of these products in the context of the crisis."
For Dsuvia specifically, Gottlieb referenced the opioid multiple times as a Pentagon priority, citing its potential use on the battlefield to treat soldiers through its sublingual formulation. The Defense Department paid for R&D activities for Dsuvia through a 2015 contract in search for a replacement to using morphine injections, according to AcelRx's Securities and Exchange Commission filings.
In a Nov. 2 statement released by the consumer group Public Citizen, the chairman of the FDA's Anesthetic and Analgesic Drug Products Advisory Committee criticized the decision, reiterating his opposition he had previously voiced last month in a letter to FDA leaders.
"This action is inconsistent with the charter of the agency," wrote Brown, who is also a professor of anesthesiology and pediatrics at the University of Kentucky's medical school. "Clearly the issue of the safety of the public is not important to the commissioner, despite his attempts to obfuscate and misdirect."
Additionally, four Democratic senators had urged Gottlieb to deny approval on Dsuvia until Brown and other drug safety committee members could participate in the decision and vote, in a letter they sent last Wednesday.
For AcelRx, Dusvia's approval was an important accomplishment, but one that will now set up what is expected to be a challenging road to market uptake and acceptance beyond the DOD.
"We believe the unique features of Dsuvia are an important leap forward in the management of acute pain and patient care in these settings," AcelRx CEO Vince Angotti said in a statement. "We are committed to the safe and effective administration of Dsuvia through diligent adherence to our FDA-approved Risk Evaluation and Mitigation Strategies program."
AcelRx's stock jumped about 22% to $5.05 apiece after the news Friday. Company executives said they expect to launch Dsuvia in the first quarter of 2019.