Rexulti Shows Efficacy in Reducing Agitation in Alzheimer’s Patients
Otsuka Pharmaceutical and H. Lundbeck’s Rexulti (brexpiprazole) has shown its efficacy in a phase 3 trial in patients with agitation from Alzheimer’s dementia.
The analysis concluded that there was a statistically significant difference in the mean change from baseline to week 12 in patients given brexpiprazole compared with those who received a placebo.
Otsuka and Lundbeck plan to file a Supplemental New Drug Application (sNDA) to the FDA later in 2022 supported by this study as well as two earlier trials.
In July 2015, the FDA approved brexpiprazole as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment in adults with schizophrenia. In February 2016, the agency granted the drug fast track designation for treatment of agitation in patients with Alzheimer’s dementia.