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Somaxon required to conduct more studies of low-dose insomnia tablet for FDA submission
By Lisa Kerner
Charlotte, N.C., July 19 - Somaxon Pharmaceuticals, Inc. said it is conducting additional studies of Silenor, its low-dose oral tablet formulation of doxepin HCl for use in insomnia, in response to a request by the Food and Drug Administration.
The company began a preclinical program consisting of standard genotoxicity, reproductive toxicology and carcinogenicity studies, the results of which will be included in Somaxon's original New Drug Application for Silenor planned for the third quarter of 2007.
Somaxon's four phase 3 clinical trials in insomnia are targeted to collectively enroll about 1,200 patients, according to a company news release.
The first study, evaluating the efficacy and safety of nightly administration of 3 mg and 6 mg of Silenor in 229 adult patients with primary sleep maintenance insomnia, has been completed.
Silenor, at doses of 3 mg and 6 mg, achieved sustained, statistically significant improvements compared to a placebo on the trial's primary endpoint, wake after sleep onset, as well as on the key secondary endpoints of latency to persistent sleep, total sleep time and sleep efficiency.
Enrollment is completed in Somaxon's clinical trials evaluating the efficacy and safety of nightly administration of 1 mg and 3 mg of Silenor in elderly patients for three months and in a single dose administration of 6 mg of Silenor in patients with induced transient insomnia.
The company is continuing enrollment in the final four-week phase 3 clinical trial to evaluate the efficacy and safety of nightly administration of 6 mg of Silenor in elderly patients.
Somaxon is a specialty pharmaceutical company based in San Diego.
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