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British Medical JournalHow the FDA Approved an Antipsychotic that Failed to Show a Meaningful Benefit but Raised the Risk of Death

Brexpiprazole failed to show a clinically significant effect in studies and increased mortality, yet the FDA expedited clearance and the sponsor projects $1 billion in sales annually.

The recent FDA approval of brexpiprazole for agitation in Alzheimer’s dementia patients has ignited a debate among healthcare professionals. Despite previous efforts to reduce the use of antipsychotics in elderly patients with dementia, this new approval may reverse the trend. The drug, costing around $1,400 a month, is forecasted to generate an additional $1bn in annual sales, but serious concerns remain about its efficacy and the increased risk of mortality associated with its use.

Key Points:

  • The FDA approved brexpiprazole in May 2023, despite a 60-70% increased risk of death previously cited with antipsychotic drug use.
  • The highest efficacy observed was a 5.3 point improvement over placebo on a 174 point scale, far short of the 17 point minimal clinically important difference.
  • Mortality risk was four times higher in patients taking brexpiprazole compared to placebo over a 16-week period.
  • The FDA fast-tracked the approval, raising questions about the drug’s superiority over other antipsychotics.

Additional Points:

  • The FDA found the first two placebo-controlled clinical trials unconvincing, and the results from the third study were also below the minimal clinically important difference.
  • Concerns exist about the lowering of standards by the FDA, as noted by experts in the field.
  • The approval has received support from patient advocacy groups, some of which have commercial interests.


  • The FDA’s approval of brexpiprazole raises significant concerns regarding the efficacy and safety of the drug. The decision may have far-reaching implications for the treatment of Alzheimer’s dementia patients and reflects a potential shift in the FDA’s standards for drug approval.

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“The small benefits do not outweigh serious safety concerns. Like other antipsychotics, this is a drug that can kill patients without providing a meaningful benefit.”

Nina Zeldes
Health Researcher at Public Citizen
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