Acute Agitation treatment gets fast track designation by FDA

The Food and Drug Administration (FDA) has granted Fast Track designation to BXCL501 (BioXcel Therapeutics [BTI]), an investigational treatment for acute agitation.BXCL501 is a sublingual film formulation of dexmedetomidine, a selective alpha 2a receptor agonist, which in both preclinical and clinical studies, has been found to impart anti-agitation effects.

Dexmedetomidine as a solution for intravenous infusion is widely used for clinical anaesthesia and sedation in an intensive care setting.

According to the Company, a Phase 1 placebo-controlled, dose-escalation study of BXCL501 is expected to enroll up to 60 healthy adults across various dosing groups; pharmacokinetics and safety will be evaluated as primary endpoints. Top-line data is expected in the first half of 2019.