Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX), a specialty pharmaceutical company, today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for claims in U.S. patent application no. 11/781,165. This patent application generally relates to dosing Silenor at least three hours after a meal to promote faster onset of action and reduce the potential for next-day residual sedation. A Notice of Allowance is the official notification that the USPTO finds the claimed subject matter allowable and intends to issue the patent pending payment of the issue fee. Given this action, Somaxon expects the patent to issue within the next few months. Once issued, this patent will expire no earlier than July 2027. Somaxon will list the patent in the Orange Book once it is issued.
“This food effect patent will further bolster our Silenor patent estate, and we expect that it will provide us with a significant opportunity to drive Silenor growth well into the next decade,” said Richard W. Pascoe, Somaxon’s President and Chief Executive Officer. “The pharmacokinetic changes that result from dosing Silenor within three hours after a meal have important implications relating to both the efficacy and safety of the product that are described in the Silenor prescribing information.”
Silenor is a low-dose (3 mg, 6 mg) oral tablet formulation of doxepin, and is the first and only non-scheduled prescription sleep medication approved to treat insomnia characterized by difficulty with sleep maintenance. Sleep maintenance is defined as waking frequently during the night and/or waking too early and being unable to return to sleep.
Important Safety Information
A doctor should be consulted if insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing the sleep problem.