Knobias Clip Report (07-12-2008) NRGN
Submitted By Knobias ClipReport
NRGN: Shares Decline on Suspension of Clinical Trial of Adipiplon for Insomnia
By Fain Hughes, fhughes@knobias.com
Shares of Neurogen Corporation (NRGN) declined on Monday after the Company announced that, based upon reports from initial dosing of a higher than anticipated rate of unwanted next day effects, the Company has suspended dosing in the Phase 2/3 study of adipiplon in chronic insomnia patients. Neurogen believes that the bilayer tablet formulation of adipiplon being used in the study may not be performing as expected.
Stephen R. Davis, Neurogen’s President and CEO, explained in a conference call today, “Higher than anticipated rate of events the next day included grogginess and amnesia events. The rates of occurrence suggest that the drug at two treatment arms was too high. We have suspended the study while we evaluate the bilayer tablets. This evaluation will likely take two to three months.”
He noted, “These events were not reported as serious and had not been observed in previous studies. The levels of the drug in patients were higher that we had previously observed.”
“As we get additional information, we will be quick to report it.”
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