FDA rules Otsuka marketing claim overstates Rexulti efficacy, threatening cornerstone of huge TV push

The FDA has ruled a claim that Otsuka made again and again overstates the efficacy of Rexulti. While Otsuka, which spends big on Rexulti TV spots, has repeatedly claimed its product is proven to reduce depression symptoms 62% more than an antidepressant alone, the FDA found no basis for the figure. 

Officials from the FDA set out their concerns in an untitled letter. The untitled letter refers to a TV ad titled “REXULTI MDD 2023-B TV Ad - See the Signs.” In the TV spot, a voice-over states that “when added to an antidepressant, Rexulti was proven to reduce depression symptoms 62% more than the antidepressant alone.” Otsuka, which sells the drug with Lundbeck, made the same claim in a banner ad.

While the FDA refers to a specific TV spot and online banner ad, a review of other Rexulti promotions shows Otsuka has quoted the figure again and again. Otsuka made the claim in a TV spot that first ran in February 2020 and repeated it across a string of ads up to a promotion it ran in May 2023. In the ads, the 62% claim is typically delivered by a physician to a patient who still has symptoms despite taking medication. 

In the untitled letter, the FDA walks through a series of analyses of the data on Rexulti. The upshot? None of the figures for the reduction in depression symptoms calculated by the FDA came close to 62%. The FDA contrasts the 62% claim with the outputs of its calculations: 4.8%, 7.4% and 11.9%. 

The FDA acknowledged that Otsuka included the caveat “individual results may vary” in the TV spot. Yet, in the administration’s view, the inclusion of the line “does not mitigate the misleading impression created by the promotional communications of the magnitude of benefit that patients can expect when taking Rexulti and an [antidepressant].”

Officials sent the letter at the end of last month and gave Otsuka 15 working days from the date of receipt to address their concerns. The officials asked Otsuka to list all promotional communications for Rexulti that contain the 62% claim and explain “any plan for discontinuing use of such communications, or for ceasing distribution of Rexulti.”