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FDA Approves Sub-q for Schizophrenia – Uzedy

The FDA recently approved a new subcutaneous specialty therapy, Uzedy (risperidone) from TEVA and MedinCell, an atypical antipsychotic indicated for the treatment of schizophrenia in adults.

It may be surprising that we are reporting on a recent drug approval that was originally FDA approved 30 years ago….. yep, 1993. However, the new and improved Uzedy is a possible game changer for patients with schizophrenia. Till now, patients were prescribed either oral risperidone administered daily or intramuscular injections.

Sticking to the prescribed dosing for risperidone has been a huge challenge for patients with schizophrenia. However, Uzedy is now extended release with either monthly or bi-monthly dosing….. and, is also sub-q which makes this formulation much more patient friendly. The company said 3.5 million people in the U.S. are currently diagnosed with the condition and approximately 80% of patients experience multiple relapses over the first five years of treatment usually coupled with therapy discontinuance. 

Uzedy will be available in the U.S. in “the coming weeks” at a wholesale cost of $1,232 to $3,080 per month, depending on the dosage strength (on par with other IM versions of risperidone). Other injectable forms of risperidone are available at retail so it is likely that Uzedy will similarly be open access.

CLICK HERE for prescribing information

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New treatment provides adults living with schizophrenia a long-acting formulation that offers flexible 1- and 2-month dosing intervals

In a Phase 3 clinical trial, UZEDY demonstrated up to 80% reduction in risk of schizophrenia relapse versus placebo1

UZEDY is a subcutaneous injection from a pre-filled syringe with a 21-gauge needle

APRIL 28, 2023 PARSIPPANY, N.J., TEL AVIV & PARIS–(BUSINESS WIRE)– Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and MedinCell (Euronext: MEDCL) announced today that the U.S. Food and Drug Administration (FDA) has approved UZEDY (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. 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………………..

Click Here to access the full TEVA press release

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