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

Orexigen(TM) is evaluating zonisamide SR as a novel component in EMPATIC(TM) Phase IIb obesity trial

SAN DIEGO, June 07, 2007 /PRNewswire-FirstCall/ -- Orexigen(TM) Therapeutics, Inc. , a biopharmaceutical company focused on the treatment of central nervous system disorders with an initial focus on obesity, today announced results from a Phase I trial evaluating safety and pharmacokinetics of its novel, proprietary, sustained-release (SR) formulation of zonisamide. In the study, the SR formulation of zonisamide achieved a significant reduction in the incidence of spontaneous adverse events compared to an immediate release (IR), legacy formulation. Zonisamide SR is a key component in the Company's obesity product candidate Empatic(TM) and is presently being evaluated in a large, Phase IIb multi-center study.

The Phase I trial was a single-center, randomized, double-blind, single- dose, crossover study in 36 healthy, normal volunteers and compared legacy zonisamide IR to an equivalent dose of zonisamide SR. Adverse events were reported by 45.7% of subjects receiving the IR formulation versus only 8.5% receiving Orexigen's SR formulation. The most frequent overall adverse event was headache; six subjects receiving zonisamide IR reported headache, while none of those receiving zonisamide SR experienced headaches. As hypothesized by the Company when initiating the SR program, a relationship between adverse events and the peak free drug concentration (Cmax) of zonisamide was demonstrated. Across all subjects, zonisamide SR exhibited a lower Cmax than the legacy IR formulation, while retaining a similar overall exposure or area under the curve.

Results from a Phase II proof-of-concept trial evaluating Empatic formulated with zonisamide IR in combination with bupropion SR for the treatment of obesity were previously reported at the North American Association for the Study of Obesity (NAASO) in October 200
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