The open label, multi-dose, safety and pharmacokinetic (PK) study is expected to enroll around 46 subjects with schizophrenia or schizoaffective disorder.
Relday has been designed to offer potentially significant improvements over current long-acting injection treatment options for these patients.
In a single-dose Phase I trial in schizophrenic patients, Relday showed 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.
According to the company, this pharmacokinetic profile of Relday may reduce 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.
Additionally, dose-proportionality for Relday has been established across all doses, as well as the duration of treatment being consistent with once-monthly dosing.
Compared to the existing long-acting injectable treatment options which are administered via intramuscular injection, Relday is administered subcutaneously and it does not require reconstitution prior to use.
During the trial, patients will be administered Relday or Risperdal Consta (risperidone), an approved long-acting intramuscular injectable with the same active ingredient as Relday.
Patients who were given 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.
The company intends to report results from the Relday multi-dose study in the third quarter of 2015 as well as plans to start efforts to secure an ex-US strategic development and commercialization partner for Relday during this development stage and is targeting an end-of-Phase II meeting with the FDA by early 2016.