A little stumble for competitor Somaxon:
>>Somaxon Pharmaceuticals Provides Update on SILENOR(TM) Development Program
Wednesday May 9, 8:00 am ET
SAN DIEGO--(BUSINESS WIRE)--Somaxon Pharmaceuticals, Inc. (NASDAQ:SOMX - News) today provided an update on its non-clinical program for SILENOR(TM) (doxepin HCl), its lead product candidate that has completed a successful Phase 3 clinical program for the treatment of insomnia.
On May 8, 2007, Somaxon received correspondence from the U.S. Food and Drug Administration (FDA) in which the FDA stated that the results of the company's ongoing 26-week transgenic mouse carcinogenicity study of SILENOR(TM) should be included as part of the initial New Drug Application (NDA) submission for SILENOR(TM). This request may result in the company delaying its initial NDA submission until the first quarter of 2008.
Somaxon continues to plan to conduct the standard two-year carcinogenicity study and to submit the results of this study as a post-NDA approval commitment.
Ken Cohen, Somaxon's President and CEO, said, "Our assumption based on previous FDA correspondence was that we could file our NDA without this transgenic mouse carcinogenicity data and provide this data during the NDA review process. While our NDA preparation activities continue as planned, we intend to discuss this latest communication with the FDA."
As previously disclosed, based on a request Somaxon received from the FDA in May 2006, the company initiated a preclinical program for SILENOR(TM) consisting of standard genotoxicity, reproductive toxicology and carcinogenicity studies. The FDA indicated that the data from the genotoxicity studies and reproductive toxicology studies should be included in the NDA for SILENOR(TM). The FDA also indicated that depending on the outcome of the genotoxicity studies, it may be flexible as to the timing of the conduct of the carcinogenicity studies, including the potential that the data from those studies may be submitted as a post-NDA approval commitment.
In September 2006, Somaxon completed the genotoxicity studies and submitted the results to the FDA. No signal indicative of genotoxicity was found in any of the assays. In February 2007, the FDA agreed with the company's assessment that SILENOR(TM) does not appear to have genotoxic potential. The FDA indicated that, unless other preclinical data raise a concern, a complete assessment of the carcinogenic potential of SILENOR(TM) may not be needed prior to NDA approval. The FDA also indicated that it may accept the results of a shorter-term carcinogenicity study for approval of the NDA and allow the standard two-year carcinogenicity study to be completed as a post-NDA approval commitment.
The reproductive toxicology studies are ongoing, and Somaxon expects to complete them in the first half of 2007. The 26-week transgenic mouse carcinogenicity study has been initiated. The company is also conducting dose range finding studies in preparation for a standard two-year carcinogenicity study.<<
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Cheers, Tuck |
