The US Food and Drug Administration (FDA) has approved UZEDY, a new drug for the treatment of schizophrenia. Manufactured by Teva Pharmaceutical Industries, Ltd., UZEDY uses copolymer technology to slowly release the active ingredient, risperidone, over a period of one to two months.
According to studies, the majority of patients with schizophrenia experience multiple relapses over the first five years of treatment, often because they don’t adhere to their oral antipsychotics (OAs) regimen. In clinical trials, the newly approved injectable demonstrated up to 80 percent reduction in the risk of relapse compared to placebo.
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UZEDY uses a novel delivery system called SteadyTeq, which was developed by the company MedinCell. Administered via a pre-filled syringe, the copolymer technology gradually controls the release of risperidone over time, providing a steady and consistent dose of the medication.
Experts applauded the approval in comments to Psychiatrist.com.
“This is the first time we have a subcutaneous LAI that can be given every two months. That it comes in a prefilled syringe makes it even more convenient,” said Leslie Citrome, MD, president of the American Society of Clinical Psychopharmacology.
Christoph Correll, MD, professor of psychiatry at the Zucker School of Medicine, Hempstead, NY, said, “As a clinician, I am excited to now have a new treatment option that reduces the risk of relapse for this complex disease and helps address some of the barriers around receiving schizophrenia treatment.”
Clinical Trials
The FDA approved UZEDY based on data from two phase 3 trials: Risperidone Subcutaneous Extended-Release Study, or the RISE study, and the Study to Test TV-46000 for Maintenance Treatment of Schizophrenia, or the SHINE Study.
RISE was a randomized, double-blind, placebo-controlled trial that enrolled 444 adult patients with schizophrenia who had been stable on oral risperidone for at least four months prior to enrollment. The study randomly assigned patients to receive either UZEDY or a placebo injection every two months. UZEDY reduced the risk of relapse by up to 80 percent compared to placebo.
SHINE was a 56-week, open-label, multicenter study that evaluated the safety and tolerability of UZEDY. This trial included 336 subjects with schizophrenia who had been stable on oral risperidone for at least four months prior to enrollment. Patients received UZEDY once a month or once every two months, depending on their individual needs. Patients tolerated the medication well, and its safety profile was similar to that of oral risperidone.
Both patients and healthcare providers took a companion survey that asked about their experience with the medication. The majority of respondents found it easy to administer and receive the medication. Notably, most patients preferred UZEDY to their previous long-acting injectable. Given the choice between continuing to take the clinical trial medication or returning to their previous treatment, 90 percent of patients opted for UZEDY.
Potential Reactions
Patients with a known hypersensitivity to risperidone or any of its components cannot take UZEDY. Most antipsychotic drugs, including UZEDY, increase the risk of death in elderly patients with dementia-related psychosis. The medication has not undergone testing or approval for use in older patients. Additionally, it has not been fully evaluated for use in a pediatric population, during pregnancy, or while lactating.
Potential adverse reactions are similar to other antipsychotics, the trials found. UZEDY may cause serious side effects such as stroke, tardive dyskinesia, and a potentially fatal symptom complex known as neuroleptic malignant syndrome. There is also some risk for other metabolic, cardiovascular, neurological, and cognitive changes. The most common side effects from the drug included movement problems, sedation, dizziness, gastrointestinal issues, weight gain, and respiratory infections. Some people also experienced a rash at the injection site.
UZEDY will be available in a few weeks, Teva said in an announcement. The list price will range from $1,232 to $3,080 per month depending on dosage strength. But the company said the actual costs for patients will be lower after discounts, rebates, and insurance coverage.
More On Injectables
This was a big week for long acting injectables (LAIs). Otsuka America Pharmaceutical, Inc. and Lundbeck announced FDA approval for a New Drug Application (NDA) of the medication ABILIFY ASIMTUFII (aripiprazole.) Like UZEDY, this drug requires a once-every-two-months injection. It’s approved for the treatment of schizophrenia in adults and for maintenance monotherapy treatment of bipolar I disorder in adults.
Jose M. Rubio, MD, an assistant professor at Feinstein Institutes for Medical Research in New York, said that the time has come for long acting injectables in schizophrenia treatment. (Rubio, who is a consultant for Teva, did not comment specifically in regards to UZEDY.)
“We are very lucky in schizophrenia that we have antipsychotic drugs that come as long acting formulations,” Rubio said. “I’m sure that if you talk to cardiologists or people who are taking care of patients with diabetes, etc., they would love to have an option that comes as long acting injectable. We are just lucky enough that we have it and I think that it makes much sense to to use it for relapse prevention.”
