Zogenix Reports Positive Top-Line Results From Extended Relday(TM) Phase 1 Clinical Trial
The extended Phase 1 clinical trial included a 100 mg dose of Relday, following previously reported positive results with 25 and 50 mg doses. The results for the 100 mg dose showed that risperidone blood concentrations in the therapeutic range were achieved on the first day of dosing, and maintained throughout the one-month period. In addition, dose proportionality has now been established across the full dose range that would be anticipated to be used in clinical practice (50 to 100 mg). The 100 mg dose was safe and well-tolerated, with no unexpected adverse events, including injection site reactions, as compared to the initial Phase 1 clinical trial with the 25 and 50 mg doses. The adverse events were generally mild to moderate and consistent with other risperidone products.
"With the positive top-line results from the Relday Phase 1 extension, we believe that we have now confirmed the product candidate's viability across the anticipated commercial dosing range," said
In connection with these partnering activities,
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 global long-acting injectable antipsychotic market was approximately
If approved, Relday has the potential to be the first subcutaneous antipsychotic product that allows for once-monthly dosing.
The Phase 1 clinical trial for Relday was conducted as a single-center, open-label, safety and PK trial of 40 patients with chronic, stable schizophrenia or schizoaffective disorder across a dose range of 25, 50 and 100 mg.
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