Decades-Old Schizophrenia Drug Wins Approval For New Formulation

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The FDA approved Weltruza, Teva’s once-monthly subcutaneous olanzapine injection for adults with schizophrenia. The formulation does not require loading doses or the three-hour post-injection monitoring required for an older long-acting olanzapine product, although its label still warns about post-injection delirium/sedation syndrome and other risks.

The U.S. Food and Drug Administration approved Weltruza, a once-monthly subcutaneous formulation of olanzapine for adults with schizophrenia, Teva Pharmaceuticals announced on October 9. The long-acting injection does not require loading doses or routine post-injection monitoring for delirium or sedation, requirements that have complicated use of an older long-acting olanzapine product.

Weltruza is intended to provide a longer-acting option using olanzapine, a medication used for schizophrenia for decades. The drug is widely prescribed in oral form, but taking a daily medication can be difficult for some patients. Teva said the injection reaches therapeutic blood levels without oral co-treatment, loading doses or booster injections. The product will be available in 318 mg, 425 mg and 531 mg doses, corresponding to approved oral olanzapine doses of 10 mg, 15 mg and 20 mg, respectively.

Approval was supported by the phase III SOLARIS trial. In results cited by Teva, every studied dose performed better than placebo on the primary measure, change in total score on the Positive and Negative Syndrome Scale (PANSS), from baseline to week eight. The mean differences ranged from -9.71 to -11.27 points, with P<0.001 for each comparison. Teva also reported favorable results on measures of clinical global impression and personal and social functioning. No cases of post-injection delirium/sedation syndrome (PDSS) occurred in the trial.

The reported safety profile was generally consistent with oral olanzapine. Common adverse events included weight gain, sleepiness, headache and constipation; injection-site effects included pain, hardening, redness, itching and swelling. The product’s labeling still lists PDSS as a warning, despite no cases being reported in the trial. It also includes a boxed warning about increased mortality risk in elderly patients with dementia-related psychosis and warnings about other potential adverse effects.

A Monthly Option Without Routine Observation

The approval adds a monthly dosing option for adults who use olanzapine, potentially reducing the number of medication-taking occasions compared with daily tablets. For patients and care teams facing difficulties with daily adherence, less frequent dosing may offer a different way to plan treatment. Whether it suits an individual depends on clinical circumstances and a discussion with a qualified health professional.

The change also addresses a practical obstacle associated with an earlier long-acting olanzapine formulation, Zyprexa Relprevv. That product carries a risk evaluation and mitigation strategy requiring three hours of monitoring after each injection because of PDSS risk. Weltruza does not require that routine monitoring under the reported approval. This distinction may affect how clinics organize administration, although it does not mean the new product is free of risk or that its label omits PDSS.

How Weltruza Differs From Older Injections

Olanzapine is an atypical antipsychotic available as an oral medication and, before this approval, as a long-acting injection. The older injectable, Zyprexa Relprevv, has been associated with PDSS, a condition involving symptoms such as agitation, anxiety and confusion after injection. Reports described people becoming confused or sedated in the hours following treatment, which is why the product has a required monitoring program.

Weltruza is also a long-acting olanzapine injection, but it is given subcutaneously once a month, according to the report. Its clinical trial did not record PDSS cases, and the new formulation does not require loading doses or routine three-hour observation. The trial findings and approval establish a new treatment option; they do not establish that all patients will respond in the same way or that the risks associated with olanzapine no longer apply.

““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, Zucker School of Medicine at Hofstra/Northwell, in Teva’s press release

Safety and Use Questions Remain

The available report does not specify when Weltruza will become available, its price, insurance coverage or which patients clinicians may consider for treatment. No cases of PDSS occurred in SOLARIS, but the product labeling still includes the syndrome among its warnings and precautions; the trial finding should not be read as proof that the risk is absent.

The source also does not provide detailed figures for all trial adverse events or enough information to compare Weltruza directly with other treatment options. Olanzapine labeling lists potential risks including metabolic changes, tardive dyskinesia, neuroleptic malignant syndrome, orthostatic hypotension, seizures and cognitive or motor impairment. Patients should discuss medication choices and risks with a qualified clinician.

Availability and Prescribing Details

Clinicians and patients will need further information about commercial availability, cost and coverage as Teva brings the approved product to market. Prescribing decisions will also depend on the final product labeling and an individual’s health history, treatment response and preferences. The approval establishes the formulation as an option; it does not indicate that patients should change an existing treatment without consulting their clinician.

Key Questions

What did the FDA approve?

The FDA approved Weltruza, a once-monthly subcutaneous olanzapine injection for adults with schizophrenia, Teva announced.

Does Weltruza require three hours of monitoring after injection?

According to the report, Weltruza does not require the routine three-hour post-injection monitoring required under the safety program for the older product Zyprexa Relprevv. Weltruza’s labeling still includes PDSS as a warning.

What supported the approval?

Approval was supported by the phase III SOLARIS trial. Teva reported that all studied doses outperformed placebo on the primary PANSS measure at week eight, and no PDSS cases occurred in the trial.

What side effects were reported?

Common adverse events in the reported safety findings included weight gain, somnolence, headache and constipation. Injection-site reactions included pain, induration, redness, itching and swelling. The label lists additional warnings and risks.

When will Weltruza be available?

The source report does not give a commercial launch date, price or coverage details. Patients should ask a qualified clinician about treatment options and consult the manufacturer or insurer for availability and payment information.

Source: rss