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FDA Approves Once-Monthly Olanzapine Injection for Schizophrenia
The U.S. Food and Drug Administration (FDA) has approved olanzapine (Weltruza), the first once-monthly injection given under the skin to treat adults with schizophrenia.
The new treatment offers an alternative to daily pills. It also doesn’t require additional oral olanzapine or routine observation after each injection, potentially making treatment more convenient for some people living with schizophrenia.
What Is Weltruza?
Weltruza is a long-acting injectable form of olanzapine, an antipsychotic medication used to help manage schizophrenia symptoms. Unlike daily oral olanzapine, Weltruza slowly releases medication into the body over time.
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Continue with EmailA healthcare professional gives the injection under the skin of the abdomen once a month. People starting Weltruza may first need to take oral olanzapine to make sure they can tolerate the medication.
Clinical Trial Found Improvements in Schizophrenia Symptoms
The FDA based its approval on the phase 3 SOLARIS trial, which included 675 adults with schizophrenia. Researchers compared three doses of Weltruza with a placebo (an inactive treatment) during the first eight weeks of the study.
After eight weeks, participants receiving Weltruza showed significantly greater improvements than those receiving a placebo in measures of:
On a scale measuring schizophrenia symptoms, Weltruza groups improved by about 22 to 23 points after eight weeks, compared with about 12 points in the placebo group.
What Are the Safety Considerations?
As with any treatment, Weltruza may cause side effects.
The most common side effects reported in the trial included:
- Weight gain
- Sleepiness
- Headaches
- Constipation
- Reactions at the injection site
It’s important to discuss potential side effects with your healthcare provider before starting a new treatment.
What Does This Approval Mean for People With Schizophrenia?
The approval gives people living with schizophrenia another treatment option, particularly those who find it difficult to remember or manage daily medication. A once-monthly injection may offer greater convenience while helping manage symptoms and support everyday functioning.
However, Weltruza may not be the right choice for everyone. Its potential benefits must be weighed against side effects and individual health needs.
If you’re living with schizophrenia and interested in alternatives to your current treatment plan, consider speaking with your mental healthcare team about what other treatments may be available. They can help you compare options based on your symptoms, medical history, and preferences.
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