BioXcel’s agitation drug gets FDA Fast Track

The FDA has granted Fast Track Designation to BioXcel Therapeutics’ BXCL501 for the treatment of acute agitation resulting from neurological and psychiatric disorders like Alzheimer’s and schizophrenia. BioXcel is a clinical-stage biopharmaceutical development company utilizing novel artificial intelligence (AI) approaches to identify new candidate medicines across neuroscience and immuno-oncology.
BXCL501 is a first in class, the proprietary sublingual film of dexmedetomidine, a selective alpha 2a receptor agonist intended for the treatment of acute agitation. The company says it believes that BXCL501 directly targets a causal agitation mechanism and has demonstrated anti-agitation effects in preclinical and clinical studies and that the drug has a well-established regulatory and reimbursement path for the acute treatment of agitation in schizophrenia and bipolar disorder, as demonstrated by Adasuve, a drug previously approved by the FDA.