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DURECT Corp Licensee Zogenix Inc Announces Positive Results from Relday Phase 1 Clinical Trial


Thursday, 3 Jan 2013 07:35am EST 

DURECT Corp announced that its licensee, Zogenix Inc, reported positive single-dose pharmacokinetic (PK) results from the Phase 1 clinical trial of Relday, an investigational candidate of a , once-monthly subcutaneous formulation of risperidone for the treatment of schizophrenia. According to Zogenix, adverse events in the Phase 1 trial in patients diagnosed with schizophrenia were generally mild to moderate and consistent with other risperidone products. The Phase 1 clinical trial for Relday was conducted as a single-center, open-label, safety and PK trial of 30 patients with chronic, stable schizophrenia or schizoaffective disorder. Per Zogenix, based on the favorable safety and PK profile demonstrated with the 25 mg and 50 mg once-monthly doses tested in the Phase 1 trial, Zogenix has extended the study to include a 100 mg dose of the same formulation. The addition of this dose arm to the study will enable evaluation of dose proportionality across the full dose range that would be anticipated to be used in clinical practice. Zogenix expects to complete the extension of the Phase 1 clinical trial during the second quarter of 2013. 

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