FDA Policy/General

Rexulti Ads ‘False and Misleading’: OPDP

The CDER Office of Prescription Drug Promotion (OPDP) says an Otsuka direct-to-consumer TV ad and computer banner ad for Rexulti (brexpiprazole) tablets make false or misleading claims and representations about the drug’s efficacy. A 10/31 Untitled Letter says the violation is “especially concerning because major depressive disorder … is a significant public health concern and the promotional communications create a misleading impression regarding the effectiveness of Rexulti, a drug with multiple serious, potentially life-threatening or irreversible risks.”

The letter says Rexulti is indicated for adjunctive treatment of major depressive disorder in adults. The drug labeling contains Boxed Warnings about increased mortality in elderly patients with dementia-related psychosis and increased risk of suicidal thoughts and behaviors in patients aged 24 and younger.

OPDP says the TV ad misleadingly suggests that patients can expect to experience a 62% reduction in depression symptoms when added to an antidepressant alone. It says the 62% claim is far greater than the reduction of 11.9% calculated from study data.

While the TV ad and banner include a statement that individual results may vary, OPDP says, that does not mitigate the misleading impression created by the promotional communications of the magnitude of benefits that patients can expect from taking Rexulti with an antidepressant.

Otsuka was told to respond with a list of all promotional communications for Rexulti that contain representations like those described in the letter, with a plan for discontinuing their use or stopping the distribution of the drug.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome