FDA approves olanzapine injection for schizophrenia

All 3 monthly doses improved schizophrenia symptoms versus placebo in the phase 3 SOLARIS trial.

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The FDA approved once-monthly subcutaneous olanzapine (Weltruza) for adults with schizophrenia.
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The long-acting formulation requires no loading dose, oral supplementation, or routine postinjection monitoring.
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In the 675-participant SOLARIS trial, all 3 monthly doses met the primary end point of change in PANSS total score at week 8.
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Weight gain occurred in 35% of olanzapine-treated patients and 8% of placebo recipients during the 8-week placebo-controlled period.
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No PDSS cases were reported through week 56, but the prescribing information states that whether PDSS can occur with olanzapine remains unknown.

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