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Somaxon Stock Perks Up With News

Somaxon Pharmaceuticals Inc. announced Dec. 18 positive results from its final clinical trial for potential sleeping pill Silenor.

Stock for the San Diego-based biotechnology firm was trading up nearly 4 percent at $14.66 midday on the day of the announcement. The 12-week, double blind, placebo-controlled study involving 240 elderly patients with chronic insomnia showed the drug, doxepin, worked well. The trial tested how well patients slept through the night with a 1-milligram dose versus a 3-milligram dose, as well as some placebo patients.

Somaxon plans to file a New Drug Application with the Food and Drug Administration in 2007.

Executives said in a conference call with investors the morning of the announcement that the phase three study is the “longest clinical trial reported to date for insomnia that evaluated efficacy in both the sleep laboratory and outpatient settings.”

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Whereas most currently approved drugs promote sleep through the GABA neurotransmitter system, according to Somaxon, Silenor works by blocking histamine receptors in the central nervous system. The company said this makes Silenor less addictive and less likely to cause amnesia or hallucinations.

“The patient assessments have been good,” said President and Chief Executive Officer Kenneth Cohen in the conference call. “They say the drug helps them, and they don’t have a lot of side effects.”

Somaxon trades on the Nasdaq as SOMX.

Another San Diego company aiming to get a piece of the multi-billion-dollar sleep-aid market is Neurocrine Biosciences Inc., whose sleeping pill candidate, Indiplon, was mostly rejected by the FDA this year. The FDA had cited concern about how Indiplon would affect elderly patients and how it would react with certain fatty foods. The federal agency is requiring that firm to conduct more studies on its drug. Neurocrine plans to resubmit its 5- and 10-milligram doses to the FDA by the second quarter of 2007.

While a 15-milligram dose of Indiplon was seen as a potential major competitor to currently marketed sleeping pills, Silenor would target mostly the elderly population.

Doxepin is already FDA-approved for depression and anxiety in much higher doses.

, Katie Weeks


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