The subcutaneous, long-acting formulation of risperidone uses MedinCell’s SteadyTeq technology for ensuring a steady release of risperidone
UZEDY is a subcutaneous, long-acting formulation of risperidone. (Credit: Vinzenz Lorenz M from Pixabay)
Teva Pharmaceuticals and MedinCell have been granted approval by the US Food and Drug Administration (FDA) for UZEDY (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adult patients.
The subcutaneous, long-acting formulation of risperidone uses MedinCell’s SteadyTeq copolymer technology for ensuring a steady release of risperidone.
UZEDY, as per the companies, is a subcutaneous injection from a pre-filled syringe with 21-gauge needle. It will be introduced in the US in the coming weeks.
According to Teva Pharmaceuticals and MedinCell, within six to 24 hours of a single dose of the drug, therapeutic blood concentrations are reached. The treatment initiation does not need any loading dose or oral supplementation.
MedinCell CEO Christophe Douat said: “The approval of the first product formulated with our technology is a pivotal moment for MedinCell and for the many patients who will benefit.
“We are committed to supporting patients through innovative therapy options. It continues to be a wonderful journey with Teva, an ideal partner to harness the full potential of UZEDY.”
The FDA approval of UZEDY was based on the results of two phase 3 clinical trials, RISE and SHINE. RISE expands to Risperidone Subcutaneous Extended-Release while SHINE is a study to assess the drug candidate for maintenance treatment of schizophrenia.
The RISE trial was held at multiple centres with 544 patients randomly grouped in a 1:1:1 ratio to be subjected to a subcutaneous injection of TV-46000 (UZEDY) once monthly, once every two months, or placebo.
SHINE, which involved 336 patients, assessed the use of TV-46000 subcutaneously administered once monthly or once every two months or up to 56 weeks.
In one of the phase 3 clinical studies, UZEDY showed a reduction of up to 80% in the risk of relapse of schizophrenia, when compared to placebo.
Teva Pharmaceuticals president and CEO Richard Francis said: “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.
“The approval of UZEDY is a culmination of a multidisciplinary effort across Teva and MedinCell to bring this important treatment to market.”