Biopharmaceutical company Impel NeuroPharma said on Friday that it has received encouraging results from Phase 1 trial of INP105 for the treatment of acute agitation in bipolar I disorder and schizophrenia.

Acute agitation often manifests in people living with serious mental health conditions, such as bipolar I disorder or schizophrenia. Agitation episodes related to neuropsychiatric disorders account for approximately 1.7 million visits to the ER each year, placing a significant economic and resource burden on the healthcare system.

The company added that INP105 is a drug-device combination that delivers an optimised formulation of olanzapine, the current gold standard of treatment for acute agitation, via its proprietary Precision Olfactory Delivery, or POD, nasal delivery device.

In the Phase 1 trial, a randomised, 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. INP105 reached peak plasma levels (Tmax) twice as fast as intramuscular olanzapine (Zyprexa) and ten-times faster than orally-disintegrating tablets (ODT, Zyprexa Zydis).

According to the company, the 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.