Impel NeuroPharma has announced results from a Phase 1 PK trial of INP105 intranasal olanzapine demonstrating that the intranasal formulation achieved Tmax two times faster than Zyprexa intramuscular olanzapine and ten times faster than Zyprexa Zydis orally disintegrating tablets, with similar Cmax and AUC to the intramuscular formulation and higher plasma levels compared to the oral formulation.
The SNAP 101 trial, which enrolled 36 healthy volunteers, compared 3 doses of INP105 to 5 mg and 10 mg doses of Zyprexa and to 10 mg of Zyprexa Zydis. Impel had announced dosing of the first patient in the study in August 2018.
Impel President and CEO Jon Congleton commented, “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.”
Read the Impel Neuropharma press release.
