Zogenix Announces First Patient Dosed in Relday Multi-Dose Clinical Study

Loading...
Loading...
Zogenix, Inc.
ZGNX
, a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders, announced today that dosing has begun in patients enrolled in its Relday™ multi-dose Phase 1b clinical study. Relday is a proprietary, long-acting, subcutaneously injected formulation of risperidone being investigated for the treatment of schizophrenia. Relday has been designed to provide potentially significant improvements over current long-acting injection treatment options for patients suffering from schizophrenia. In a Phase 1 single-dose clinical study in schizophrenic patients, Relday demonstrated the ability to achieve therapeutic plasma levels of risperidone on the first day of dosing, followed by a controlled release profile over the remaining four-week period. This pharmacokinetic profile of Relday may eliminate the requirement for long-acting risperidone injections to be supplemented with daily oral therapy for several weeks during therapy initiation or when patients are not fully compliant with an injection regimen over the course of long-term therapy. In addition, dose-proportionality for Relday has been established across all doses, as well as the duration of treatment being consistent with once-monthly dosing. Unlike all currently marketed long-acting injectable treatment options which are administered via intramuscular injection, Relday is administered subcutaneously. Moreover, unlike some leading injectable products in the category, Relday does not require reconstitution prior to use. Fifty-six subjects with schizophrenia or schizoaffective disorder are planned to be enrolled in this open label, multi-dose, safety and pharmacokinetic (PK) study. Subjects will be administered Relday or Risperdal® Consta® (risperidone), an approved long-acting intramuscular injectable with the same active ingredient as Relday. Patients being administered Risperdal Consta will also receive daily oral risperidone supplementation during a three-week initiation period, and will be dosed every two weeks, as required by its prescribing label. Subjects will be followed for up to 20 weeks in order to confirm and compare the time to reach drug concentrations within the therapeutic range and to compare steady state pharmacokinetics for Relday and Risperdal Consta. The Company anticipates that results from the Relday multi-dose study will be available in the third quarter of 2015. The Company also plans to initiate efforts to secure an ex-U.S. strategic development and commercialization partner for Relday during this development stage and is targeting an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) by early 2016. If completed, these milestones would position the Company to begin a Phase 3 clinical study for Relday in 2016. Brad Galer, M.D., chief medical officer of Zogenix, stated, "We are pleased to move the Relday development program forward into this next clinical study. We expect the data to continue to demonstrate that Relday's novel formulation has a differentiated product profile amongst currently marketed long-acting injections for the treatment of schizophrenia that should enhance the treatment for this patient population." In July 2011, Zogenix licensed from DURECT
DRRX
exclusive global rights to develop and commercialize this proprietary formulation which utilizes DURECT's SABER® depot technology.
Loading...
Loading...
Posted In: NewsFDAPress Releases
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...