Decades-Old Schizophrenia Drug Wins Approval for New Formulation

The FDA approved an easier-to-use once-monthly subcutaneous injectable form of olanzapine (Weltruza) for schizophrenia in adults. The new long-acting injectable requires no loading doses and no monitoring for post-injection delirium/sedation syndrome (PDSS), an issue that has hampered uptake of other available long-acting olanzapine formulations such as Zyprexa Relprevv, which carries a risk evaluation and mitigation strategy program requiring 3 hours of monitoring for PDSS. To match the approved oral olanzapine doses (10 mg, 15 mg, and 20 mg), the new long-acting injectable will be available in doses of 318 mg, 425 mg, and 531 mg, respectively.