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News Breaks
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November 5, 2009
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| 16:28 EDT |  | SOMX |
| theflyonthewall.com: | Somaxon Pharma updates status of Silenor | | Somaxon held a meeting with the FDA, where the FDA stated that to obtain approval of a chronic insomnia treatment, objective and subjective efficacy must be established in adult and elderly patient populations, and efficacy must be shown both at the beginning of treatment and on a persistent basis, defined as at least one month. No additional safety issues were raised in the meeting, and the FDA has not requested that the company conduct additional clinical trials of Silenor. Based on the feedback it received at the meeting, Somaxon conducted additional analyses of its clinical data focused on the durability of subjective sleep maintenance efficacy in adults with primary insomnia. The company completed these analyses and included the results in a June 4 resubmission of the NDA to the FDA. The resubmission also included the results of the company's completed clinical trial of doxepin that evaluated the potential for ECG effects that were previously submitted to the company's investigational new drug application for Silenor. The FDA has accepted the resubmission for review and confirmed that the review cycle will be six months, resulting in a new FDA action date of December 4. Based on the Complete Response Letter and its meeting with the FDA, Somaxon will no longer pursue approval of a 1 mg dose of Silenor, nor will it seek approval of a statement in the indication section of the label that clinical trials of Silenor have demonstrated improvement in sleep onset. :theflyonthewall.com |
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February 10, 2012
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| 07:59 EDT |  | SOMX |
| theflyonthewall.com: | Somaxon downgraded to Neutral from Buy at Roth Capital | | Roth Capital downgraded Somaxon due to shrinking Silenor prescriptions. Price target is 75c. :theflyonthewall.com |
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January 31, 2012
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| 11:21 EDT |  | SOMX |
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