Just before the weekend, the U.S. Food and Drug Administration gave its approval for a new, powerful and fast-acting opioid medication, despite serious concerns that it will only add to the current addiction crisis. The product, manufactured by small San Francisco-area pharmaceutical company, was approved by an FDA committee by a 10-3 vote.
The company, AcelRx Pharmaceuticals, specializes in pain therapies. It developed the new painkiller as an alternative to standard IV-administered analgesics for situations in which an IV is not practical, such as on-site emergencies, outpatient care, and battlefield first aid. According to company literature, Dsuvia (sufentanil) is:
“…for the management of moderate-to-severe acute pain in a variety of medically supervised settings, including in emergency medicine, outpatient or ambulatory surgery, non-surgical patients experiencing pain in the hospital, or post-operative patients, following short-stay surgery, who do not require more long-term analgesia.”
The key phrase is “medically supervised.” In an attempt to reassure critics who fear the new drug will make a bad situation worse, FDA Commissioner Scott Gottlieb issued a written statement:
“There are 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. . . . We’ll work to quickly make regulatory adjustments if problems arise.”
AcelRx co-founder and Chief Medical Officer Pamela Palmer M.D., an anesthesiologist, adds that the danger of the drug winding up in the hands of those likely to abuse it is very low. Pointing out that Dsuvia will not be available to patients through prescription (its use is limited to medical care facilities), she says, “It will not contribute to the large outpatient opioid crisis.”
Raeford Brown, M.D., chairman of the FDA committee that voted to approve Dsuvia, is not reassured. One of the three committee members who voted against approval, he said, “We have worked very diligently over the last three or four years…to reduce the number of potent opioids on the street. I don’t think this is going to help us in any way.” Significantly, Brown – who has been opposed to the approval of a number of opioid-based medications – was unable to attend the meeting at which Dsuvia approval was discussed because of a prior commitment of which he had informed the committee several months ago.
The committee meeting also excluded members of the Drug Safety and Risk Management Committee, who usually participate in decisions on opioid medications. Although an FDA spokesperson said their absence was “due to scheduling conflicts,” the consumer watchdog organization Public Citizen says they were not invited to the meeting. In addition, a letter from four U.S. Senators, asking that approval be delayed until the Drug Safety Committee could attend was completely disregarded. In a press release issued Friday, Public Citizen said the “FDA rigged [the] committee vote to ensure a positive recommendation.”
Dr. Palmer also argues that the new potent medication, which is delivered orally under the tongue, fills a unique, unmet need for fast-acting analgesics in difficult situations. “If you want to get on top of someone’s pain quickly, you have to come up with a different route than swallowing a pill.”
Dr. Sidney Wolfe of Public Citizen, who has spoken out before on the topic of ill-advised FDA approvals, disagrees. Pointing out that Dsuvia was inadequately tested and not nearly as fast-acting as AcelRx suggests, Wolfe says “It’s not unique at all.” He noted that in two of the company’s own studies, it took an average of 1.1 hours for patients to experience “meaningful” relief.
Another prominent pain medicine specialist, Dr. Palmer McKee, director of the Eskenazi Health Integrative Pain Program in Indianapolis, said, “It’s not like we need it…at some level, it’s going to be diverted.”
Wolfe’s final assessment: “The FDA really screwed up.”