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San Diego’s Somaxon Readies to Wake Up Market for New Sleeping Pill

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the company closely, it’s worth mentioning the highlights.

— Somaxon expects to launch the drug in the second half of 2010 and is in discussions with third parties about a marketing partnership or some other relationship. (Observers I spoke with say a specialty pharma company is the likeliest candidate.)

— Psychiatrists write a large percentage of sleeping pill prescriptions and Somaxon believes it can target them with a specialty sales force of 50 to 100 reps.

— Somaxon plans to distribute free samples that doctors can give to their patients to encourage early trial and to build word-of-mouth. (The company is banking that physicians will feel comfortable handing out the pills because doxepin, unlike zolpidem, is not a scheduled drug.)

— Somaxon needs to strengthen its balance sheet. The company had cash of $5.2 million at the end of 2009, enough to get through the first half of 2010. (The company since made plans to sell 6 million shares at $8.25 per share to raise $45.9 million. It expects to complete the offering by March 31.)

— Somaxon says it won’t need a massive budget to promote its product, because ads for competing prescription drugs have virtually dried up. In other words, it won’t have to shout to be heard.

Doxepin is a low-dose formulation of an old drug that was first marketed as an antidepressant in 1969. In clinical studies, doxepin posed no risk of dependency or addiction, a marketing advantage over zolpidem that Somaxon intends to emphasize. Sixty-five percent of people who take prescription sleeping pills report their chief worry is getting hooked on the medication, Somaxon says.

The drug was approved to promote sleep maintenance, meaning it helps people sleep through the night but doesn’t necessarily help them fall asleep. The company says that in clinical trials, the drug helped subjects get seven to eight hours of sleep.

How the drug works in the real world remains to be seen. Subjects who took the drug in some clinical trials performed slightly worse on memory tests given one hour after waking compared to those in a placebo group. People who take the drug on a full stomach may experience such next-day impairments according to information on the drug label approved by the FDA.

This is a story we’ll be watching. Eyes wide open.

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