Impel NeuroPharma announced positive results of a Phase 1 trial of INP105. INP105 is a drug-device combination which delivers an optimized formulation of olanzapine, the current gold standard of treatment for acute agitation, via Impel's proprietary Precision Olfactory Delivery, or POD®, nasal delivery device. INP105 is being studied for the treatment of acute agitation in bipolar I disorder and schizophrenia. Results demonstrated that INP105 reached peak plasma levels (Tmax) twice as fast as intramuscular olanzapine (Zyprexa®), and ten-times faster than orally-disintegrating tablets (ODT, Zyprexa Zydis®). Maximum and total plasma levels (Cmax and AUC) were similar to intramuscular delivery and exceeded the total plasma levels for ODT. Pharmacodynamic measures of sedation, including Visual Analogue Scale (VAS), the Agitation and Calmness Evaluation Scale (ACES) and Digit Symbol Substitution Test (DSST) all showed a robust statistical significance compared to placebo. In the trial, a randomized, double-blind, placebo-and-active controlled, two-period crossover design, the overall safety and tolerability profiles of INP105 were similar to Zyprexa and Zyprexa Zydis. The most common adverse events (at least two events for any treatment) were dizziness (including postural), headache, nasal congestion, rhinorrhea, hypotension, orthostatic hypotension, fatigue, restlessness, nausea and orthostatic tachycardia.