Somaxon Pharmaceuticals, Inc. (NASDAQ:SOMX), a specialty pharmaceutical company, today announced that the U.S. Patent and Trademark Office has issued U.S. patent no. 7,915,307, entitled “Methods of Improving the Pharmacokinetics of Doxepin.” This patent generally relates to dosing Silenor® (doxepin) at least three hours after a meal to promote faster onset of action and reduce the potential for next-day residual sedation. This patent will expire no earlier than July 2027, and Somaxon has submitted to the U.S. Food and Drug Administration the required information to list the patent in the Orange Book.
“Our most important corporate objective is to maximize sales of Silenor, and the issuance of this new patent relating to the Silenor food effect is an important catalyst in that effort because it expands the scope and duration of Silenor’s patent exclusivity,” said Richard W. Pascoe, Somaxon’s President and Chief Executive Officer. “Based on Silenor’s differentiated clinical efficacy and safety profile, its non-scheduled status and the reaction to the product to date from physicians and patients, we see significant growth potential for Silenor. We will continue to direct our Silenor commercial efforts at those activities which we believe can deliver meaningful results in 2011 and beyond.”
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.
Patients should be sure that they are able to devote 7 to 8 hours to sleep before being active again. Silenor should be taken within 30 minutes of bedtime. Patients should not take Silenor with alcohol or with other medicines that can cause drowsiness. Silenor should not be taken with or within two weeks after taking a monoamine oxidase inhibitor (MAOI). Patients should not take Silenor if they have untreated narrow angle glaucoma, if they have severe urinary retention, if they have severe sleep apnea or if they are allergic to any of the ingredients in Silenor. Until patients know how they will react to Silenor, they should not drive or operate machinery at night after taking Silenor, and they should be careful in performing such activities during the day following taking Silenor. Before taking Silenor, patients should tell their doctors if they have a history of depression, mental illness or suicidal thoughts. Patients should call their doctors right away if after taking Silenor they walk, drive, eat or engage in other activities while asleep. Drowsiness was the most common adverse event observed in clinical trials.