Agitation constitutes up to 10% of psychiatric intervention. Summarized by 5 behavioural elements (poor impulse control, tension, hostility, uncooperativeness and excitement), agitation affects a significant proportion of patients diagnosed with schizophrenia, dementia, substance abuse, and bipolar or anxiety disorders. Current management techniques, including restraint and seclusion, are costly, traumatic and often require prolonged hospitalization. To protect the relationship between patients with chronic psychiatric conditions and their healthcare professionals, non-coercive management strategies are required.
After meeting all Phase Ib endpoints, BioXcel Therapeutics has recently initiated two Phase III trials to assess the efficacy of BXCL501 as an acute treatment for agitation in patients with schizophrenia (SERENITY I) and bipolar disorder (SERENITY II). Initiation of a Phase Ib/II trial for dementia-associated agitation is also expected this year.
A potential first-in-class treatment, BXCL501 has received Fast-T is a sublingual film of dexmedetomidine, a selective α2a receptor agonist, and aims to treat agitation independent of the underlying disease by reducing the activity of brain norepinephrine, which regulates the body’s fight-or-flight response. A New Drug Application submission is expected in the second half of 2020.