Somaxon Pharmaceuticals Inc. (SOMX) said on Monday that the US Food and Drug Administration, or FDA, has extended the review period for the company's New Drug Application for Silenor for up to three additional months.
The company noted that the review will be completed by February 28, 2009 instead of the originally scheduled date of December 1.
Silenor is a low-dose oral tablet formulation of doxepin that is patent-protected for use in insomnia.
Richard Pascoe, Somaxon's president and chief executive officer, said, "The FDA did not raise any issues with the data contained in the NDA, nor did they request that we conduct any additional studies. We have had numerous interactions with the FDA during its review of the NDA, and we have been very responsive to all questions posed during the review cycle. We will continue to work closely with the FDA toward the potential approval of Silenor."
Pascoe also said the company will take certain cost-cutting measures and will continue to evaluate financing alternatives in order to ensure that its financial position is as strong as possible during the remainder of the NDA review period.
SOMX is currently trading at $1.56, down 19 cents or 10.86%.
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