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www.fdanews.com/articles/108575-neurogen-experiences-setback-in-insomnia-study

Neurogen Experiences Setback in Insomnia Study

July 15, 2008

Neurogen’s planned Phase II/III trial with its insomnia drug adipiplon has been suspended due to side effects.

In prior studies, subjects were simultaneously administered doses of immediate-release and controlled-release forms of the drug. The latest study was the first trial in which the two forms were laminated into one bilayer tablet, which failed to meet expectations and caused unwanted next-day effects in patients.

Neurogen said it is evaluating the situation before deciding whether to continue additional studies with the drug.