Relday risperidone: Interim Phase I data
Top-line data from an open-label, U.S. Phase I trial in 30 patients with chronic, stable schizophrenia or schizoaffective disorder showed that single doses of 25 and 50 mg once-monthly subcutaneous Relday produced a "favorable safety and PK profile." Zogenix said adverse events were generally mild to moderate and consistent with other risperidone products. Based on the results, Zogenix expanded the trial to include a cohort of 10 patients to receive a 100 mg dose of Relday. The extension is expected to complete in 2Q13. The company is developing the product under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. ...