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

Zogenix, Inc. (Nasdaq: ZGNX), apharmaceutical company developing and commercializing products for thetreatment of central nervous system (CNS) disorders, announced today thatdosing has begun in patients enrolled in its Relday™ multi-dose Phase 1bclinical study. Relday is a proprietary, long-acting, subcutaneously injectedformulation of risperidone being investigated for the treatment ofschizophrenia.Relday has been designed to provide potentially significant improvements overcurrent long-acting injection treatment options for patients suffering fromschizophrenia. In a Phase 1 single-dose clinical study in schizophrenicpatients, Relday demonstrated the ability to achieve therapeutic plasma levelsof risperidone on the first day of dosing, followed by a controlled releaseprofile over the remaining four-week period. This pharmacokinetic profile ofRelday may eliminate the requirement for long-acting risperidone injections tobe supplemented with daily oral therapy for several weeks during therapyinitiation or when patients are not fully compliant with an injection regimenover the course of long-term therapy. In addition, dose-proportionality forRelday has been established across all doses, as well as the duration oftreatment being consistent with once-monthly dosing. Unlike all currentlymarketed long-acting injectable treatment options which are administered viaintramuscular injection, Relday is administered subcutaneously. Moreover,unlike some leading injectable products in the category, Relday does notrequire reconstitution prior to use.Fifty-six subjects with schizophrenia or schizoaffective disorder are plannedto 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 sameactive ingredient as Relday. Patients being administered Risperdal Consta willalso receive daily oral risperidone supplementation during a three-weekinitiation period, and will be dosed every two weeks, as required by itsprescribing label. Subjects will be followed for up to 20 weeks in order toconfirm and compare the time to reach drug concentrations within thetherapeutic range and to compare steady state pharmacokinetics for Relday andRisperdal Consta. The Company anticipates that results from the Reldaymulti-dose study will be available in the third quarter of 2015.The Company also plans to initiate efforts to secure an ex-U.S. strategicdevelopment and commercialization partner for Relday during this developmentstage and is targeting an end-of-Phase 2 meeting with the U.S. Food and DrugAdministration (FDA) by early 2016. If completed, these milestones wouldposition 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 tomove the Relday development program forward into this next clinical study. Weexpect the data to continue to demonstrate that Relday's novel formulation hasa differentiated product profile amongst currently marketed long-actinginjections for the treatment of schizophrenia that should enhance thetreatment for this patient population."In July 2011, Zogenix licensed from DURECT (Nasdaq: DRRX) exclusive globalrights to develop and commercialize this proprietary formulation whichutilizes DURECT's SABER® depot technology.