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OREXIGEN Therapeutics Announces Sustained-Release Formulation of,Zonisamide Shows Improved Tolerability When Compared to Immediate,Release Formulation

6. Empatic was associated with significant weight reduction through 48 weeks of treatment but also early discontinuations due to adverse events in approximately 37% of study participants. Zonisamide appeared to be the principal contributing factor, as a similar rate of discontinuations was evident among subjects receiving zonisamide IR therapy alone. Orexigen, in partnership with PharmaDirections, Inc. developed the proprietary SR formulation of zonisamide with the objective of improving its overall tolerability.

"We are excited that our novel, sustained release formulation of zonisamide was significantly better tolerated than the existing generic IR formulation. This is an important consideration in conditions such as obesity that often require longer-term maintenance therapy. Based on these results, we are eagerly awaiting the outcome of our ongoing 24 week Phase IIb multi-center study of Empatic, which incorporates our proprietary formulation of zonisamide SR," said Gary Tollefson, M.D., Ph.D., Orexigen's President and CEO.

About Orexigen(TM) Therapeutics

Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the development of pharmaceutical product candidates for the treatment of central nervous system disorders, with an initial focus on obesity. Orexigen's lead combination product candidates targeted for obesity are Contrave(TM), which is in Phase III clinical trials, and Empatic(TM) (formerly Excalia(TM)), which is in a Phase IIb clinical trial. Both product candidates take advantage of the Company's understanding of how the brain appears to regulate appetite and energy expenditure, as well as the mechanisms that come into play to limit weight loss over time. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss. Further information about the Company can be found at




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