09:12 AM EDT, 04/22/2024 (MT Newswires) -- BioXcel Therapeutics ( BTAI ) said Monday it plans to initiate an at-home phase 3 trial of BXCL501, a potential treatment for agitation linked to bipolar disorder or schizophrenia, based on the US Food and Drug Administration's feedback.

The trial aims to enroll around 200 patients, who will self-administer 120 mcg of BXCL501 or placebo during agitation episodes over 12 weeks, BioXcel said.

The primary goal of the study is to assess safety, while efficacy measures serve as exploratory endpoints to evaluate BXCL501's use in outpatient settings, according to the company.