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Somaxon Pharmaceuticals, Inc. - NASDAQ

4/19/2014, 6:20 PM ET
Quote & Analysis Breaking News StockTalk Description
Sector: Healthcare
Country: United States

We are a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area. We submitted our NDA for Silenor® (doxepin) to the FDA on January 31, 2008. The FDA accepted the NDA for filing effective March 31, 2008. Pursuant to Prescription Drug User Fee Act, or PDUFA, guidelines, the FDA was expected to complete its review and provide an action letter with respect to the NDA by December 1, 2008. However, in November 2008, the FDA indicated that its review of the NDA would be extended for up to three additional months, resulting in a new PDUFA date of February 28, 2009.

On February 25, 2009, we received a complete response letter from the FDA relating to the NDA. The FDA stated that based on its review the NDA could not be approved in its present form. In the complete response letter the FDA raised a number of issues relating to the interpretation of the efficacy data contained in the NDA and indicated that the FDA was open to a discussion of these concerns. The FDA did not specifically request us to conduct additional clinical trials of Silenor. We believe that a discussion with the FDA will be necessary to gain a complete understanding of the implications of the issues raised in the complete response letter, and we have scheduled a meeting with the FDA for April 6, 2009.

With respect to safety, the FDA noted that there were no adverse events observed in the clinical studies included in the NDA that would preclude approval, but asked us to address the possibility that doxepin may prolong the cardiac QT interval. We have responded by submitting to the FDA the results of our completed clinical trial of doxepin that evaluated the potential for electrocardiogram, or ECG, effects. The results of this clinical trial demonstrated that doxepin had no effect on QT interval prolongation when administered at 6 mg or under exaggerated exposure conditions of 50 mg.

We believe that the data contained in the NDA, together with the data from the cardiac study that we submitted, are sufficient to support a determination by the FDA that Silenor can be approved for the treatment of insomnia. We believe that Silenor is highly differentiated from currently available insomnia treatments, and if approved, could have significant advantages in a large and growing market. Based on data from IMS Health, in 2008 the prescription market for the treatment of insomnia grew approximately 7% compared to 2007 to more than 63 million prescriptions. According to IMS Health, the insomnia market accounted for more than $2 billion in sales in 2008 despite the introduction in April 2007 of generic versions of Ambien, which was the leading prescription product at the time.

We have undertaken activities to prepare for the commercial launch of Silenor if it is approved by the FDA. In addition, we continue to engage in discussions with third parties relating to the commercialization of Silenor.

As of December 31, 2008, we had 22 employees, consisting of clinical development, regulatory affairs, manufacturing and program management, business development, marketing and administration. In March 2009 we undertook a reduction in force that will result in us having 14 full-time employees as of April 1, 2009.

We make available free of charge on or through our internet website our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports as soon as reasonably practicable after such material is electronically filed with or furnished to the Securities and Exchange Commission. Our internet address is Information is also available through the Securities and Exchange Commission’s website at or is available at the Securities and Exchange Commission’s Public Reference Room located at 100 F Street, NE, Washington DC, 20549. Information on the operation of the Public Reference Room is available by calling the Securities and Exchange Commission at 800-SEC-0330.