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www.fdanews.com/articles/96256-orexigen-therapeutics-reports-data-on-phase-iib-trial-of-empatic

Orexigen Therapeutics Reports Data on Phase IIb Trial of Empatic

July 24, 2007

Orexigen Therapeutics announced positive topline results at the 24-week primary endpoint of its Phase IIb trial of its obesity drug Empatic.

The randomized, double-blind, placebo-controlled trial, conducted with the company’s sustained release (SR) formulation of zonisamide paired with bupropion SR, evaluated various ratios of bupropion and zonisamide in 620 patients, Orexigen said.

At the highest dose tested, patients experienced 8.6 percent weight loss from baseline compared with 1.1 percent weight loss for placebo in the intent-to-treat group, and 10.3 percent weight loss from baseline compared to 1.2 percent weight loss for placebo in the completer group, the company said.

According to the company, the trajectory of weight loss for all treatment arms appeared to continue downward through the 24-week period, and results of the trial indicated that Empatic is safe and generally well-tolerated.