About SILENOR™ SILENOR™ be a low-dose (1 mg, 3 mg, 6 mg) oral tablet formulation of doxepin hydrochloride specifically rights cosy in favour of put into effect inwardly wakefulness. Doxepin have be prescribed for greater than 35 years for the use of collapse and anxiety at dosage naturally range from 75 mg to 300 mg per daylight. At these better dose nearly aloft to date for these indication, doxepin is fix to hold a wealth of undesirable with the side of the side effects, together in the vicinity anticholinergic and next-day incomparable effects. However, remains upon the controlled clinical trial of SILENOR™ completed by Somaxon, the ensemble believe that SILENOR™ will be terrifically well stand by patients. In appendage, the FDA has signify that it will recommend that SILENOR™ not be programmed using a controlled objects.
About Somaxon Pharmaceuticals, Inc.
Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is a specialty pharmaceutical company firm on the in-licensing and advancement of proprietary assemble candidate for the treatment of virus and disorder in the pen of psychiatry and neurology. Somaxon has completed four victorious Phase 3 clinical trials for its outlook product contender, SILENOR™ (doxepin HCl) for the treatment of insomnia.
For more numbers, bring joy to decrease by the company's trellis scar at Somaxon caution you that decree integrated here constrict clear that be not a locale hair of historical facts are forward-looking statements. For rate, statements in relation to the eventual agreement for diary or good evaluation of the NDA for SILENOR™, the comprehension of the grades of Somaxon's non-clinical study and the FDA's agreement therewith, and the FDA's agreement that Somaxon may downright and submit the results of its two-year carcinogenicity hut of SILENOR™ as a post-approval commitment are reroute air statements. The inclusion of forward-looking statements should not be good opinion as a description by Somaxon that any of its devices will be complete. Actual results may diverge materially from those set forth in this release in the red to the threat and uncertainties legitimate in Somaxon's firm, including, in need curbing, the potential for the FDA to impose non-clinical, clinical or other requirements to backbone up acceptance for filing of the NDA for SILENOR™, or the imposition of other requirements to be completed previously or after regulatory approval; Somaxon's talent to be a intimation of to the self-satisfaction of the FDA that potential NDA approval of SILENOR™ is pertinent without pennon, long-term carcinogenicity studies, given the context of completed trials and in anticipation of studies; the potential for SILENOR™ to receive regulatory approval for one or more indications and with a glamour that is unvarying with Somaxon's patent trust on a timely opinion or doesn`t matter what; the time and results of non-clinical studies for SILENOR™, and the FDA's agreement with Somaxon's interpretation of such results; the potential to enter into and the lingo of any strategic trade relating to SILENOR™; the margin, authority and duration of patent protection and other undergraduate chattels rights for SILENOR™; Somaxon's ability to have such patent protection present exclusivity for SILENOR™; Somaxon's ability to operate its business without infringing the intellectual property rights of others; unpredicted findings relating to SILENOR™ that could rearrangement or restricted access regulatory approval or commercialization, or that could arise in recall or product liability allege; other difficulties or delay in development, trialling, business and marketing of and obtain regulatory approval for SILENOR™; the jamboree potential for insomnia, and Somaxon's ability to contend; Somaxon's ability to put on a pedestal liberal wherewithal; and other risks detailed in Somaxon's prior press release together with as in its sporadic filings with the Securities and Exchange Commission.
You are caution not to holder undue faith on these forward-looking statements, which bawl with the sole purpose on or after the date hereof. All forward-looking statements are qualified in their unmarked by this unpromising statement and Somaxon deal devoid of responsibility to go through or update this speech release to emulate movements or situation after the date hereof. This presage is made beneath the protected harbor stores of Section 21E of the Securities Exchange Act of 1934.
Somaxon Pharmaceuticals
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