Bipolar disorder is a serious, lifelong medical condition. Credit: Lucy Mills.

Impel NeuroPharma has reported positive results from the Snap 101 Phase I trial evaluating the safety and tolerability of INP105 in comparison with ODT, zyprexa and zydis for the treatment of acute agitation in bipolar I disorder and schizophrenia.

INP105 is a drug-device combination designed to deliver olanzapine, the current standard of treatment for acute agitation, through Impel’s Precision Olfactory Delivery (POD) nasal delivery device.

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The results showed that INP105 achieved peak plasma levels (Tmax) twice as fast as intramuscular olanzapine (zyprexa).

Compared to orally-disintegrating tablets such as ODT, Zyprexa Zydis, INP105 was also found to be ten-times faster.

As per the new data, maximum and total plasma levels (Cmax and AUC) of INP105 were consistent with intramuscular delivery and were more than the total plasma levels for ODT.

“The results of this trial are very encouraging and initial conversations with the US Food and Drug Administration have indicated the potential for a streamlined development program.”

INP105 demonstrated improved statistical significance in pharmacodynamic measures of sedation such as visual analogue scale (VAS), agitation and calmness evaluation scale (ACES) and digit symbol substitution test (DSST) than placebo.

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Impel NeuroPharma president and CEO Jon Congleton said: “The results of this trial are very encouraging and initial conversations with the US Food and Drug Administration have indicated the potential for a streamlined development program given the current unmet need for bipolar and schizophrenia patients who experience episodes of acute agitation.

“We are excited that Impel NeuroPharma’s drug-device clinical programs, including INP105, are progressing rapidly and we anticipate multiple data readouts and regulatory filings across the portfolio in the next 18-24 months.”

The SNAP 101 trial featured a randomised, double-blind, placebo-and-active controlled, two-period crossover design.

It compared three ascending doses of INP105 with two doses of zyprexa and orally disintegrating zyprexa zydis in 36 healthy subjects.

Brain imaging studies showed differences in the volume of various brain regions between patients with bipolar disorder and healthy control subjects.