Zogenix Reports Positive Results From Relday(TM) Phase 1 Clinical Trial
Based on the favorable safety and PK profile demonstrated with the 25 mg and 50 mg once-monthly doses tested in the Phase 1 trial,
Because this approach involves selecting the dose by administering different volumes of the same formulation by a healthcare professional, the development of Relday will first focus on delivery by conventional needle and syringe while accelerating the overall program timeline. The introduction of the DosePro needle-free technology can occur later in development or as part of life cycle management after further work involving formulation development, technology enhancements, and applicable regulatory approvals.
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 will 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 30 patients with chronic, stable schizophrenia or schizoaffective disorder. The study will be extended to include an additional cohort of 10 patients at a 100 mg dose.
For additional information, please visit www.zogenix.com.
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