FDAnews
www.fdanews.com/articles/108573-orexigen-initiates-second-phase-ii-empatic-trial

Orexigen Initiates Second Phase II Empatic Trial

July 15, 2008

Orexigen Therapeutics has begun randomizing patients in its second Phase IIb clinical trial for Empatic, one of the company’s late-stage obesity product candidates.

The trial is based on safety and efficacy results from a previous Phase IIb trial of the drug. Those results demonstrated weight loss after 48 weeks that ranged from roughly 11 percent to 15 percent in obese patients who completed the trial, Orexigen said.

Empatic combines zonisamide and bupropion, which have been independently approved by the FDA to treat central nervous system disorders.