First Trial of Relday Begun - Drug Discovery and Development

Zogenix Inc., a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, announced that it has initiated its first IND clinical trial for Relday, a product candidate based on a combination of its
DosePro needle-free, subcutaneous drug delivery system with a proprietary, subcutaneous once-monthly formulation of risperidone for treating schizophrenia. 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. Further study information can be found at https://www.clinicaltrials.gov and reference NCT01592110.

Roger L. Hawley, chief executive officer of Zogenix, said, “Relday represents a significant opportunity to leverage our proprietary DosePro needle-free drug delivery system in combination with a novel long-acting formulation of an established antipsychotic to provide psychiatrists and their patients with an improved treatment option. We look forward to completing this trial by the end of the year which we believe will enable us to begin discussions with potential partners for rest-of-world development and commercialization.”

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 $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.

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’s SABER controlled-release depot technology in combination with Zogenix’s DosePro needle-free subcutaneous drug delivery system.

Date: July 12, 2012
Source: Zogenix Inc.