Significant investors in Somaxon Pharmaceuticals appear set for further sleepless nights with news that the FDA has rejected the company’s application for insomnia drug, Silenor, sending shares crashing 84% to a record low of just 35 cents in early trade today.Although the FDA has not asked for additional clinical trials, the regulator raised a number of issues regarding efficacy and safety data submitted in the filing. In particular the FDA would like to see data that addresses concerns the drug may prolong cardiac QT interval, a request which had previously been highlighted as a significant risk associated with the regulatory filing (Event - Waiting game might not be over for Somaxon, October 31, 2008).
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