Zogenix Reports Positive Top-Line Results From Relday(TM) Phase 1b Multi-Dose Clinical Trial
Product Candidate Now Phase 3 Ready
Company Initiates Efforts to
The Phase 1b multi-dose parallel group clinical trial enrolled 60 subjects comprised of three cohorts of patients receiving four monthly injections of Relday, at dose levels of either 60, 90 or 120 mg of risperidone per month. A fourth cohort received five bi-weekly intramuscular injections of Risperdal® Consta®. Risperdal Consta requires oral supplementation for the first three weeks following dosing initiation, and requires at least four doses to reach steady state. The results for Relday demonstrated that risperidone plasma concentrations in the therapeutic range were achieved on the first day of dosing, reached steady state levels following the second dose and consistently maintained therapeutic levels throughout the four-month period. In addition, dose proportionality was confirmed across the dose range intended for clinical practice (60 to 120 mg). Relday was generally safe and well-tolerated, with results consistent with the profile of risperidone and the Company's previous Phase 1 single-dose clinical trial.
"With the positive top-line results from the Phase 1b multi-dose trial, Relday is now well-positioned to begin a Phase 3 program once a development and commercialization partner is secured," said
Risperidone is one of the most widely prescribed medications used to treat the symptoms of schizophrenia in adults and teenagers 13 years of age and older. The injectable formulation of risperidone, Risperdal Consta, requires twice-a-month dosing, oral supplementation during therapy initiation, intramuscular injection and drug reconstitution prior to use.
If approved, Relday has the potential to be the first subcutaneous antipsychotic product that allows for once-monthly dosing and achieves therapeutic drug levels on the first day of administration.
The Phase 1b multi-dose clinical trial for Relday was conducted as a single-center, open-label, safety and PK trial of 60 patients with chronic, stable schizophrenia or schizoaffective disorder across a dose range of 60, 90 and 120 mg, and included a comparator arm of Risperdal Consta.
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Andrew McDonaldFounding Partner, LifeSci Advisors LLC646-597-6987 | Andrew@lifesciadvisors.com