Posted by Michael Wonder on 12 Nov 2020
BioXcel Therapeutics announces completion of pre-NDA meeting with FDA for BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorders
11 November 2020 - Initiated rolling submission of new drug application with U.S. FDA.
BioXcel Therapeutics today announced that it has completed its pre-NDA meeting with the FDA for BXCL501 for the acute treatment of agitation in patients with schizophrenia and bipolar disorders.
BXCL501, which received fast track designation from the FDA, is the Company’s novel, proprietary, orally dissolving, sublingual thin film formulation of dexmedetomidine.
The purpose of the meeting was to discuss the FDA’s expectations regarding the content and formatting of the NDA submission to ensure that all requirements for a complete application are met.
