Teva Pharmaceuticals, a U.S. affiliate of Israel’s Teva Pharmaceutical Industries Ltd., won approval from the U.S. Food and Drug Administration (FDA) for its UZEDY (risperidone) extended-release injectable suspension medication for the treatment of schizophrenia in adults. Teva says UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq, a copolymer technology proprietary to MedinCell that controls the steady release of risperidone. Therapeutic blood concentrations are reached within 6-24 hours of a single dose.
UZEDY (risperidone) extended-release injectable suspension, for subcutaneous use rather than intramuscular use, is indicated for the treatment of schizophrenia in adults. Teva said in clinical trials, UZEDY reduced the risk of relapse by up to 80%. UZEDY administers risperidone through copolymer technology under license from MedinCell that allows for absorption and sustained release in the first subcutaneous injection.
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This is a much needed win for Teva after the company in January was forced to reach a settlement with 48 U.S. states over the opioid epidemic scandal and the company’s role in it. It was only a little over a year ago that Teva Pharmaceuticals was found guilty in a NY trial of contributing to America’s opioid crisis. A jury in New York State found that Teva had in fact promoted the use of addictive painkillers.
And last May, the State of Israel launched a $100 million lawsuit against Teva Pharmaceutical Industries in the Lod District Court, alleging that the company breached its rights by not paying royalties for the multiple sclerosis drug Copaxone.
Teva explains that approximately 80% of patients with schizophrenia experience multiple relapses over the first five years of treatment, most commonly due to suboptimal adherence to treatment with oral antipsychotics. Each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.
Schizophrenia is a chronic, progressive and severely debilitating mental health disorder that affects how one thinks, feels and acts.5 This approval is based on data from two Phase 3 trials evaluating UZEDY in patients with schizophrenia: TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – A Study to Test TV-46000 for Maintenance Treatment of Schizophrenia).
“Treatments for schizophrenia are largely prescribed as daily oral medications, which can present challenges with adherence due to missed doses. Lack of adherence to treatment with oral antipsychotics is the most common cause of relapse in schizophrenia, so there’s a role for therapies that are dosed in one- or two-month dosing intervals to help prevent relapse,” said Christoph Correll, MD, professor of psychiatry at the Zucker School of Medicine, Hempstead, NY. “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.”
“UZEDY embodies Teva’s commitment to bringing innovative advances to patients and to providing people living with schizophrenia an important new treatment option that was designed to address certain treatment challenges and may decrease the risk of relapse,” said Richard Francis, President and CEO of Teva. “The approval of UZEDY is a culmination of a multidisciplinary effort across Teva and MedinCell to bring this important treatment to market. This milestone is a testament to advancing our robust biopharmaceutical pipeline of innovative medicines that aim to support more people living with mental health disorders and neurological diseases in the coming years.”
