In the complete response letter the FDA raised a number of issues relating to the interpretation of the efficacy data contained in the Silenor new drug application (NDA) and indicated that the FDA was open to a discussion of these concerns. The FDA did not specifically request the company to conduct additional clinical trials of Silenor.
With respect to safety, the FDA noted that there were no adverse events observed in the clinical studies included in the NDA that would preclude approval, but asked the company to address the possibility that doxepin may prolong the cardiac QT interval. The company intends to respond by submitting to the FDA the results of its completed clinical trial of doxepin that evaluated the potential for electrocardiogram effects.
Richard Pascoe, president and CEO of Somaxon, said: “We continue to believe that the data in the NDA we have submitted, together with the QT data we will submit, is sufficient to support a determination by the FDA that Silenor can be approved for the treatment of insomnia.
“We are committed to working with the FDA to resolve the issues raised in the complete response letter so that Silenor can be approved. As we continue to seek approval of Silenor, we will continue to take measures to conserve our cash and will evaluate financing alternatives available to us.”