A Study of Olanzapine After Intranasal and Intramuscular Administration

Summary

NRL-4, a nasal spray formulation of the atypical antipsychotic olanzapine is being developed by Neurelis Inc. for use as a rescue medication for acute episodes of agitation in schizophrenia, schizoaffective and bipolar I disorder. Also being tested are different concentrations of Intravail A3. Intravail A3 belongs to a class of nonionic surfactants known as alkylglycosides. Alkylglycosides have been extensively studied for their ability to promote increased bioavailability of drugs via the nasal, oral, and ocular routes. In this study it will be tested if the olanzapine in the two Test products will show comparable pharmacokinetics, safety and tolerability in comparison to the Reference product through the primary pharmacokinetic parameters Cmax, AUC from time 0 to time t and AUC from time 0 to infinity, and safety assessments, including nasal irritation, sedation and pain scales.

Timeline

Start

2023-10-16

Primary completion

2023-11-01

Completion

2023-11-01

Publications

• Madden S, Citrome L, Correll CU, Shih EK, Lopez-Toledano M, Rabinowicz AL, Carrazana E. A Single-Dose, Randomized, Open-Label, Parallel Design Study to Characterize the Pharmacokinetics of an Investigational Olanzapine Intranasal Spray Compared to a Reference Dose of Olanzapine Intramuscular Injection in Healthy Adult Males. J Clin Psychiatry. 2025 Mar 19;86(2):24m15665. doi: 10.4088/JCP.24m15665.

Drugs

Indications

No indication recorded.