(By Balaseshan) Zogenix Inc. (NASDAQ:ZGNX), a pharmaceutical company, said it has initiated Relday clinical trial for Schizophrenia with results anticipated before year-end.
The Phase 1 clinical trial for Relday is a single-center, open-label, safety and pharmacokinetic (PK) trial that will enroll 30 patients with chronic, stable schizophrenia or schizoaffective disorder. Zogenix expects that study results will be available by the end of 2012.
The company said Relday is a product candidate based on a combination of its DosePro needle-free, subcutaneous drug delivery system with proprietary, subcutaneous once-monthly formulation of risperidone for treating schizophrenia.
Schizophrenia is a mental disorder characterized by a breakdown of thought processes and by poor emotional responsiveness. If approved, Relday will be the first subcutaneous, needle-free antipsychotic product that allows for once-monthly dosing.
Zogenix believes that Relday will offer an improved pharmacokinetic profile, significant reduction in injection volume and a simplified dosing regimen due to DURECT Corp.'s (NASDAQ:DRRX) SABER controlled-release depot technology in combination with Zogenix's DosePro needle-free subcutaneous drug delivery system.
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 about $2 billion in 2011, with currently approved products using a 21-gauge or larger needle for intramuscular injections.
The leading product in the category requires twice-a-month dosing and drug reconstitution prior to use. The combined market for oral and injectable antipsychotic products was estimated at more than $16 billion in 2010.
ZGNX ended Wednesday's regular session down 10.53% at $2.04. The stock has been trading between $1.31 and $5.11 for the past 52 weeks.