FDA takes issue with Dsuvia marketing.
This month, the Food and Drug Administration (FDA) delivered a warning letter to AcelRx Pharmaceuticals (ACRX) concerning the “serious and potentially life-threatening risks” of Dsuvia that may result from “accidental exposure to misplaced tablets” or overdoses. The agency’s letter was aimed at addressing a website banner ad and physical tabletop display developed by the company that it felt inaccurately suggested the drug is easy to administer with limited risk. The banner included the catchy phrase ‘Tongue and Done,’ which the FDA argued suggested it is a “simple, one-step process” to use Dsuvia, when there are “numerous administration steps” outlined in the product labeling.
AcelRx responded the “FDA objected to the messaging as part of a required review of promotional materials submitted to the agency.” However, it felt it could “easily address the concerns without any financial impact, since the ads had not been used since late 2019,” according to a filing with the U.S. Securities and Exchange Commission (SEC), and “there is no restriction on manufacturing Dsuvia,” AcelRx added.
Dsuvia is designed to manage acute pain in adults, severe enough to require an opioid analgesic and for which alternative treatments have failed. It is ten times more potent than fentanyl and needs to be administered in a supervised healthcare setting, which is why the FDA took issue with the ads. The company specifically states on Dsuvia’s warning label that patients need to discontinue use prior to “discharge or transfer from the certified medically supervised healthcare setting.”
The FDA endorsed the use of Dsuvia in late 2018, despite push-back from medical experts that alternatives already exist in the market and such a powerful opioid could easily be easily diverted for illicit use. Risks include life-threatening respiratory depression, addiction, abuse, and misuse, and accidental ingestion by children can cause death. Use of Dsuvia with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may also result in respiratory depression, coma, and death.
At the time of its approval, the move was backed by the U.S. military, which argued Dsuvia was needed in combat zones to manage acute pain associated with war injuries. The military championed its approval despite the fact that trial data did not conclusively find it was effective in helping injured soldiers. The FDA endorsement was the result of a compromise reached with the U.S. Department of Defense, which felt the medication should be easier to administer than having wounded soldiers swallow a pill or starting an IV, and it provided $23 million in funding to AcelRx for development and testing.
While it was left addressing the FDA’s letter this month, AcelRx signed an agreement with Newport Plastic and Reconstructive Surgery Associates to initiate a study analyzing data from the historical use of Dsuvia for same-day plastic surgery procedures, which will focus on the efficacy and safety of the drug for use in general anesthesia cases, and “awake” cosmetic procedures performed at Newport Plastic and Reconstructive Surgery’s center. The principal investigator, Dr. Hisham Seify, is a board-certified plastic surgeon and the past-president of the Orange County Society of Plastic Surgeons, and data from a total of seventy patients will be evaluated.
“We have used Dsuvia for over a year in a wide variety of cases and there are no currently published studies focusing on plastic surgery with this sublingual analgesic, which has been a major evolution for our practice,” said Dr. Seify.