Zogenix announces positive results from Phase I schizophrenia study
Jan 08, 2013 (Datamonitor via COMTEX) -- DURECT Corporation, a provider of pharmaceutical products based on drug delivery technology platforms, has announced that its licensee, Zogenix Inc. has reported positive single-dose pharmacokinetic, or PK, results from the Phase I clinical trial of Relday, an investigational candidate of a proprietary, once-monthly subcutaneous formulation of risperidone for the treatment of schizophrenia.
According to Zogenix, adverse events in the Phase I trial in patients diagnosed with schizophrenia were generally mild to moderate and consistent with other risperidone products.
The Phase I 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 I 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 I clinical trial during the second quarter of 2013.
James Brown, D.V.M., president and CEO of DURECT, stated, "We're pleased with these results from the first Relday study and with Zogenix's extension of the study to a higher dose. We believe this formulation of risperidone, designed to be dosed once a month through a subcutaneous rather than intramuscular injection, would provide patient and clinician benefits relative to existing risperidone products. Relday joins POSIDUR (SABER-bupivacaine), for which we anticipate filing an NDA in the first quarter of 2013, as our second depot injectable therapeutic in clinical development."