BioXcel Therapeutics has reached a general agreement with the FDA on the key elements of the designs for its SERENITY (Sub-Lingual DExmedetomidine in Agitation Associated With SchizophRENIa and Bipolar Disorder STudY) program, two Phase 3 studies of BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorder.
“Our pivotal Phase 3 studies are designed to support the regulatory approval of BXCL501 as a non-injectable, acute treatment for agitation in patients with schizophrenia and bipolar disorder,” said Vimal Mehta, Chief Executive Officer of BTI. more