Longevity
FDA approves once-monthly olanzapine injection that skips sedation monitoring
By Life and Health Today Staff, . Life and Health Today.
The US Food and Drug Administration has approved a once-monthly subcutaneous injectable version of olanzapine, sold under the brand name Weltruza, for schizophrenia in adults. Teva Pharmaceuticals announced the decision on Friday, as reported by MedPage Today.
Olanzapine is an atypical antipsychotic, a class of drugs that works on dopamine and serotonin receptors in the brain to reduce psychotic symptoms. Its oral form has been in use for more than three decades and is, according to the report, the most widely prescribed drug in its class. The problem, as with many daily psychiatric medications, is that people miss doses, and missed doses can mean relapse.
Long-acting injectables exist precisely to address that. The existing long-acting olanzapine injection, Zyprexa Relprevv, carries a risk evaluation and mitigation strategy program, a formal FDA safety program, requiring three hours of post-injection monitoring for what is called post-injection delirium/sedation syndrome, or PDSS. The report described PDSS as associated with agitation, anxiety, and confusion, with some patients reported to have walked into walls or fallen asleep in public within hours of a dose. That monitoring requirement has limited how widely Zyprexa Relprevv is used.
Weltruza requires no such monitoring, no loading doses to build up the drug quickly at the start of treatment, and no booster injections between monthly doses, according to the report. The labeling does still list PDSS among warnings and precautions, even though no PDSS cases occurred in the clinical trial that supported approval.
That trial, the phase III SOLARIS study, measured the drug against placebo using the Positive and Negative Syndrome Scale, a standard tool for rating schizophrenia symptoms. According to a 2024 press release from Teva cited in the report, all three dose groups outperformed placebo at eight weeks, with mean score differences ranging from -9.71 to -11.27 points, each reaching statistical significance at p less than 0.001. Two secondary measures, the Clinical Global Impressions-schizophrenia scale and the Personal and Social Performance Scale, also showed superiority over placebo. The reporting does not give the full size of the trial population.
What the SOLARIS results do not establish is whether Weltruza performs better than existing olanzapine formulations, oral or injectable. The trial compared the new drug to placebo, not to a head-to-head competitor. The meaningful clinical question for prescribers, whether eliminating the monitoring requirement translates into better real-world adherence and outcomes compared with what is already available, remains unanswered.
Weltruza will be available in three doses, 318 mg, 425 mg, and 531 mg, corresponding to the approved oral olanzapine doses of 10 mg, 15 mg, and 20 mg respectively, according to the report.
The safety profile in SOLARIS was broadly consistent with oral olanzapine. The report lists common adverse events including weight gain, drowsiness, headache, and constipation, along with injection-site reactions such as hardening, pain, redness, itching, and swelling. The drug carries a boxed warning, the FDA's most serious label alert, over increased mortality risk in elderly patients with dementia-related psychosis, a warning shared with other antipsychotics in its class.
"Olanzapine has been a trusted and foundational treatment option for people living with schizophrenia for more than 30 years, but adherence continues to be a major barrier to stability, particularly for those who rely on daily oral medications," Christoph Correll, MD, of the Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, said in Teva's press release, as quoted in the report.
Whether the simplified administration of Weltruza will translate into broader uptake than its predecessor is a question that real-world prescribing data, not a placebo-controlled trial, will eventually answer. Anyone weighing treatment options for schizophrenia should work through those decisions with a clinician who knows their full history.
Source: https://www.medpagetoday.com/psychiatry/schizophrenia/123353
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