October 3, 2008
Orexigen Initiates Phase IIa Antipsychotic-Associated Weight Gain Study
Orexigen Therapeutics, a biopharmaceutical company focused on the treatment of obesity and other central nervous system-related disorders, has initiated its first Phase IIa clinical trial with OREX-003, a proprietary sustained release formulation of zonisamide plus olanzapine.
The Phase IIa clinical trial, OZ-101, is designed to examine the effectiveness of OREX-003 in mitigating drug-associated weight gain or other metabolic consequences commonly experienced by patients taking atypical antipsychotic medications, as well as the potential enhancement of antipsychotic activity.
The OZ-101 clinical trial is a double-blind, placebo-controlled clinical trial evaluating the combination of olanzapine plus zonisamide SR versus olanzapine plus placebo in 75 patients with schizophrenia over 16 weeks at nine centers in the US.
The company has also announced that the US Patent and Trademark Office has issued patent providing broad coverage of the use of zonisamide either alone or in combination with other drugs for the treatment of obesity through 2023.
The USPTO has also issued patent which broadly covers zonisamide in combination with various marketed atypical antipsychotics including olanzapine, clozapine, risperidone, quetiapine, aripiprazole and ziprasidone through 2025. Orexigen has licensed both patents on an exclusive basis from Duke University.
Gary Tollefson, president and CEO of Orexigen, said: "Based on our preclinical data, we believe that OREX-003 has the potential to have an improved metabolic profile and be a more effective long-term option in the management of schizophrenia and a number of related conditions."