With the FDA decision date of December 4 looming for Somaxon Pharmaceuticals Inc. (SOMX)'s amended New Drug Application for Silenor for treatment of insomnia, the stock set a new intraday high of $4.80 for the year Monday before settling down at $3.80.
This is Silenor's second go-around with the FDA. On February 26, Somaxon was issued a complete response letter for its New Drug Application for Silenor for the treatment of insomnia. In the complete response letter, the regulatory agency had raised a number of issues relating to the interpretation of the efficacy data.
Though no safety issues were raised, the FDA had asked the company to address the possibility that Silenor may prolong the cardiac QT interval.
In reply to the complete response letter, Somaxon resubmitted its New Drug Application to the FDA for Silenor for the treatment of insomnia on June 4.
The resubmission included additional statistical analyses of the company's clinical data relating to the durability of subjective sleep maintenance efficacy. It also included the results of the company's completed clinical trial of Silenor that evaluated the potential for electrocardiogram, or ECG, effects. The results of that clinical trial demonstrated that Silenor had no effect on QT interval prolongation when administered at 6 mg or under exaggerated exposure conditions of 50 mg.
According to the American Psychiatric Association, about 70 million adult Americans are affected by insomnia. The insomnia market accounted for more than $2.0 billion in sales in 2008 despite the introduction in April 2007 of generic versions of Sanofi-Aventis (SNY)' Ambien, the market leader at that time.
Somaxon is a development stage company and has not derived any revenue from product sales to date. If approved, Silenor will be the company's first commercial drug. Somaxon estimates peak annual sales for Silenor to exceed $500 million.
The company is also in discussions with third parties toward a potential commercial partnership for Silenor. If approved, Silenor is expected to be launched in the first half of 2010.
At September 30, 2009, Somaxon had total cash of $5.4 million and no debt. The company believes, based on its current operating plan, its cash on hand will be sufficient to fund its operations through the second quarter of 2010.
Will Silenor pass muster with the FDA this time? Stay tuned...
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