Number Needed to Treat and Number Needed to Harm From Two Phase 3 Studies of Sublingual Dexmedetomidine for Treating Acute Agitation in Patients With Schizophrenia and Bipolar Disorder

Abstract Background Episodes of acute agitation can occur in individuals who suffer from schizophrenia or bipolar disorder and these be a significant challenge for patients those provide care to them. Sublingual dexmedetomidine is selective alpha2-adrenergic receptor agonist that was recently approved by the US Food Drug Administration treatment adults with disorder. The sublingual form does not undergo first-pass hepatic metabolism, thus resulting greater absorption than when ingested. In two Phase 3 studies disorder, significantly reduced at 2 hours, as measured five-item Positive Negative Syndrome Scale-Excited Component (PEC). When initially appraising potential utility new medication, number needed treat (NNT) harm (NNH) helpful assess size effect and, hence, clinical relevance. Objective Calculation NNT NNH through post hoc analysis data. Methods Post data were performed on double-blind, randomized, placebo-controlled experiencing agitation. Patients randomized single dose 180 μg, 120 placebo. primary endpoint mean change baseline PEC total score. A therapeutic response defined ≥40% reduction score hours. calculated rate versus using incidence adverse events Likelihood helped harmed (LHH) ratio NNT. Results (95% CI) (2, 3) mcg (3, 4) ug 4 6) 10 all AEs except somnolence, where 7 (5, 10) doses pooled both studies. LLH values 1 efficacy applicable tolerability outcomes cases. Conclusions This demonstrated favorable dexmedetomidine. instances encountered more frequently any event. These compare favorably similar analyses other agents associated including intramuscular inhaled formulations. Funding BioXcel Therapeutics, Inc.