OPDP warns AcelRx over promotional materials

FDA’s Office of Prescription Drug Promotion (OPDP) issued its first warning letter of 2021 to AcelRx Pharmaceuticals over the company’s promotional materials for sufentanil sublingual tablet (Dsuvia). The warning letter asserts that AcelRx made false and misleading claims about the opioid in banner ads and a tabletop display, describing the ease of administration as “Tongue and Done.” The letter comes nearly 2.5 years after FDA approved sufentanil for acute pain in adults for which alternative treatments are insufficient. The drug is subject to a risk evaluation and mitigation strategy (REMS) that restricts its use to certified medically supervised health care settings. FDA wrote, “The promotional communications, the banner, and display, make false or misleading claims and representations about the risks and efficacy of Dsuvia. Thus, the banner and display misbrand Dsuvia within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and make its distribution violative. Oral opioids, such as Dsuvia, include risks for accidental ingestion, which may lead to fatal respiratory depression.” The agency also noted the banner omitted information about the maximum daily dosage of 12 tablets in 24 hours, and that the statement,”comes in one strength for acute pain,” creates a misleading impression about the drug by omitting information about its limitations of use.