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.
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