The FDA has approved Weltruza, a new long-acting injectable formulation of olanzapine, for treating schizophrenia in adults. The once-monthly subcutaneous injection is designed to address adherence issues that come with daily oral antipsychotics, which remain a major barrier to stability for many patients.
The approval was supported by the phase III SOLARIS trial, in which all dose groups showed significant improvements in PANSS total scores compared with placebo, with mean differences ranging from -9.71 to -11.27 points at week 8. Secondary endpoints also favored the drug. The injectable is available in 318 mg, 425 mg, and 531 mg doses, matching oral doses of 10 mg, 15 mg, and 20 mg.
A key advantage is that Weltruza does not require the 3-hour post-injection monitoring for PDSS that is mandated for Zyprexa Relprevv, an older long-acting olanzapine. No PDSS cases occurred in the trial, although the label still includes PDSS among its warnings and precautions. The safety profile was generally consistent with oral olanzapine, with common adverse events including weight gain, somnolence, headache, and constipation, plus injection-site reactions. As with other antipsychotics, the label carries a boxed warning about increased mortality risk in elderly patients with dementia-related psychosis.