Feb. 10 at 8:36 PM
$BTA Reg Statement S12-13: "We also intend to propose that we should not assess efficacy in this trial since we believe there are no well-defined and validated measures of efficacy for the at-home setting of acute agitation as measured by the caregiver, notwithstanding that the FDA stated that we should collect such efficacy data at our October 2023 meeting.
We believe that the efficacy of BXCL501 for the treatment of agitation in dementia patients has already been established in our Phase 3 study (BXCL501-303) and is further supported by additional efficacy data from BXCL501-103, our Phase 2 study, and from the evaluation of BXCL501 in the treatment of agitation in schizophrenia (BXCL501-301) and bipolar disorders (BXCL501-302). However, the FDA may not agree with our proposed trial design to evaluate both the safety and efficacy of BXCL501 for the acute treatment of agitation associated with dementia due to probable Alzheimer’s disease in an at-home setting.