What is UZEDY?
UZEDY (risperidone) is an extended-release injectable antipsychotic approved by the FDA in April 2023 for treating schizophrenia in adults.[1] It uses the Stealth technology platform to deliver steady risperidone levels subcutaneously once a month, without oral supplementation.[1]
How does UZEDY work?
Risperidone blocks dopamine D2 and serotonin 5-HT2A receptors in the brain, reducing psychotic symptoms like hallucinations and delusions.[1] The subcutaneous injection forms a depot that releases the drug gradually over 1-2 months, maintaining therapeutic levels with less frequent dosing than daily pills.[1]
Who makes UZEDY and when did it launch?
Teva Pharmaceuticals and MedinCell jointly developed and market UZEDY. It launched in the U.S. in May 2023.[1]
What are the dosing options?
Available in 50 mg, 75 mg, 100 mg, and 150 mg doses, administered by healthcare professionals every 4 weeks. No loading dose or oral meds needed after the first injection.[1]
How does UZEDY compare to other long-acting risperidone injectables?
Unlike intramuscular options like Risperdal Consta (every 2 weeks) or Perseris (monthly but with oral startup), UZEDY is subcutaneous, easier to administer, and provides immediate release without priming doses.[1] It matches efficacy of oral risperidone in trials but improves adherence.[1]
What do clinical trials show?
Two Phase 3 trials (RISE and SHINE) met endpoints, showing non-inferiority to oral risperidone in reducing PANSS scores for schizophrenia symptoms. Relapse rates were low (about 7%) over 56 weeks.[1]
When do UZEDY patents expire?
Key patents cover the formulation and delivery tech, with U.S. Patent No. 10,792,234 expiring in 2034 and others through 2040. Check DrugPatentWatch.com for full listings and challenges.[2]
What side effects do patients report?
Common ones include weight gain, sleepiness, headache, and injection site reactions (less than 5%). Serious risks: extrapyramidal symptoms, tardive dyskinesia, hyperprolactinemia, and metabolic changes. Monitor blood sugar and lipids.[1]
Who qualifies for UZEDY?
Adults 18+ with schizophrenia. Not for bipolar disorder or kids. Avoid in patients with hypersensitivity to risperidone or severe liver issues.[1]
How much does UZEDY cost?
Wholesale acquisition cost is $3,000-$4,500 per monthly dose, depending on strength. Patient assistance programs from Teva may lower out-of-pocket costs.[1]
[1]: FDA Label - https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215256s000lbl.pdf
[2]: DrugPatentWatch.com - https://www.drugpatentwatch.com/p/tradename/UZEDY