Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) has recently completed the genotoxicity studies for its lead product candidate for the treatment of insomnia, SILENOR™ (doxepin HCl), as requested by the USFDA.
The said studies consisted of an in vitro bacterial reverse mutation test, an in vitro mammalian chromosomal aberration test and an in vivo rodent micronucleus test to assess for chromosomal damage, in accordance to USFDA guidance.
After assessment of the results, Somaxon did not observe a signal indicative of genotoxicity in any of the assays.
Based on its assessment, the company shortly plans to submit the data to the USFDA and request that the agency permit the company to submit the data from the requested carcinogenicity studies of SILENOR™ as a post-New Drug Application (NDA) approval commitment.
Find more details from the Somaxon Pharma, Inc. press release (a pdf file).
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