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JAMA Neurology Publishes Complete Results of Positive Phase 3 Study of REXULTI® (brexpiprazole) for

New efficacy data reported for pivotal Study 213 shows significant, clinically meaningful improvements in agitation symptoms.Agitation symptoms negatively impact functioning, disease progression, quality of life and care for about half of Alzheimer’s dementia patients – and are a consistent predictor of nursing home. ....

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Highly Prescribed Drug Gets FDA Green Light Despite 4-Fold Higher Risk of Death

Highly Prescribed Drug Gets FDA Green Light Despite 4-Fold Higher Risk of Death
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Investigation Questions Drug's Approval for Agitation in AD

The agency defended approval of brexpiprazole (Rexulti) for the treatment of agitation, saying the antipsychotic fills an unmet medical need. ....

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How the FDA approved an antipsychotic that failed to show a meaningful benefit but raised the risk of death

In trials, brexpiprazole failed to provide a clinically meaningful benefit and it increased mortality, but the FDA fast tracked its approval and the sponsor predicts $1bn in annual sales. Robert Whitaker investigates the first licensed antipsychotic for treating agitation in elderly patients with dementia

For years, health officials have tried to rein in the prescribing of atypical antipsychotics to elderly patients with dementia. The practice has been entirely “off label” yet widespread. The US Food and Drug Administration reports that around 60% of patients with Alzheimer’s dementia in residential care have received an off-label prescription for an antipsychotic, benzodiazepine, antidepressant, or anti-epileptic drug. After a 2005 FDA warning that cited a 60-70% increased risk of death associated with antipsychotic drug use, the US Centers for Medicare and Medicaid Services established the National Partnership to Improve Dementia Care in Nursing Homes, a public-private c ....

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SciSparc (SPRC) Announces Successful Final Phase IIa Results, Meeting End Points of its Phase IIa Alzheimer Disease Patients with Agitation Trial

SciSparc (SPRC) Announces Successful Final Phase IIa Results, Meeting End Points of its Phase IIa Alzheimer Disease Patients with Agitation Trial
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