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# Cobenfy TV Spot ‘False or Misleading’: FDA
- URL: https://www.fdaweb.com/cobenfy-tv-spot-false-or-misleading-fda/
- Published: 2025-12-18T12:00:00.000Z
- Updated: 2026-09-14T15:29:38.000Z
- Author: David McFarland
- Tags: Drugs, FDA Policy/General, #legacy-id-D5160410

The CDER Office of Prescription Drug Promotion (OPDP) says a TV ad produced by Bristol Myers Squibb’s Karuna Therapeutics unit for its Cobenfy (xanomeline and trospium chloride) capsules, for oral use, is false or misleading. A 12/15 [Notice of Violation](https://www.fda.gov/media/190245/download?attachment&ref=fdaweb.com) describes the ad and says its claims and presentations “create a misleading representation that treatment with Cobenfy will improve both the positive and negative symptoms of schizophrenia. However, the pivotal trials supporting the schizophrenia indication for Cobenfy were not designed to capture changes in positive or negative symptoms as distinct groups.”

OPDP also says the ad misleadingly suggests that Cobenfy has efficacy in treatment-refractory cases of schizophrenia, when this has not been demonstrated.

It further says the ad’s attention-grabbing visuals during the presentation of the major statement interfere with comprehension of the statement.

Karuna was told to respond with a list of all promotional Cobenfy communications that contain representations like those described in the letter and a plan for discontinuing such communications or ceasing to distribute Cobenfy.