After three tries, Somaxon Pharmaceuticals has won FDA approval for its insomnia drug.
The San Diego-based biotech company said today it has gotten clearance to start selling doxepin (Silenor) in the U.S. for patients with short term and chronic insomnia. The news sent shares of the company (NASDAQ: SOMX) up by 60 percent to $6.20 at 1:20 pm Eastern time.
This is the first FDA-approved product for Somaxon, which was founded in 2003. Somaxon persisted after its application was turned down by the FDA in February and December 2009. The approval means that Somaxon, or whoever it might form a partnership with, will seek to differentiate the new drug from competitors like Sanofi-Aventis’ zolpidem (Ambien and Ambien CR), King Pharmaceuticals’ zaleplon (Sonata), Dainippon Sumitomo’s eszopiclone (Lunesta).
Somaxon’s drug has a different way of working than others, as I described in this feature story earlier in the week. The Somaxon product is designed to block histamine, a neurotransmitter in the brain that’s believed to help keep people awake. Clinical trials have shown that the drug can help people get a full night’s sleep including sleep into the 7th and 8th hour, the company says.
Somaxon says its market research suggests that patients often decide not to use other drugs because of the potential for abuse and dependence. Somaxon hopes to take advantage of that market desire, pointing out that there were no indications of dependence in its clinical trials that enrolled more than 1,000 patients.
The company didn’t say how much the drug will cost in its statement. The company hopes to introduce the product to the U.S. market in the second half of 2010, CEO Richard Pascoe said in a statement.
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