SILENOR tm for Insomnia. According to the American Psychiatric Association, approximately one-third of adult Americans (approximately 73 million people) are affected by insomnia. One study has found that fewer than 15% of those who suffer from insomnia are treated with prescription medications. We are developing SILENORtm for the treatment of patients with insomnia and believe that SILENORtm will offer significant benefits over currently available therapies in the insomnia market. We in-licensed the patents and the development and commercial rights to SILENORtmand intend to develop the product for the U.S. market. SILENORtm is an oral formulation of doxepin at strengths of 1 mg, 3 mg, and 6 mg. Doxepin has been marketed and used for over 35 years at dosages from 75 mg to 300 mg per day for the treatment of patients with depression and anxiety. Doxepin has a well-established safety profile and we expect that our targeted dosages will be well tolerated and provide a wide margin of safety. SILENORtm binds to H1 receptors in the brain and blocks histamine which is believed to play an important role in the regulation of sleep. The leading approved insomnia medications, Ambien, Sonata and Lunesta, work by binding and activating a different set of brain receptors known as GABA receptors. Currently approved GABA receptor-activating drugs are deemed to have the potential for abuse and are therefore designated by the Drug Enforcement Administration, or DEA, as Schedule IV controlled substances, which require additional registration and administrative controls. We have completed two placebo-controlled Phase II clinical trials, one in adults and one in elderly patients with chronic primary sleep maintenance insomnia, and we are currently conducting four Phase III clinical trials in patients with insomnia. Based on our analysis of the results of our prior clinical trials, we believe that SILENORtm will induce and maintain sleep throughout the night, without next-day residual effects, in both adult and elderly patients. We expect data from our first Phase III clinical trial to be available in the second quarter of 2006 and currently anticipate filing the related New Drug Application, or NDA, in the first quarter of 2007

EX-10.23 2 a18081exv10w23.htm EXHIBIT 10.23 Exhibit 10.23

Exhibit 10.23

SOMAXON PHARMACEUTICALS, INC.

AMENDMENT NO. 1 TO CONSULTING AGREEMENT

Reference is made to the Consulting Agreement (the “Agreement”) dated August 25, 2003 by and between Somaxon Pharmaceuticals, Inc. (the “Company”) and Terry Cobb (the “Consultant”). All capitalized terms used herein and not otherwise defined shall have the meanings assigned to such terms in the Agreement.

Whereas, the parties desire to amend certain terms of the Agreement in accordance with the terms hereof (this “Amendment”).

Now Therefore, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged by the parties, the parties hereto, intending to be legally bound, agree as follows:

Section 3.a. of the Agreement shall be deleted in its entirety and replaced by the following:

As compensation for the Services to be rendered pursuant to this Agreement from and after September 23, 2005, the Company shall pay to Consultant the sum of $10,000.00 per month, to be paid monthly on the last calendar day of each month. Compensation for Consultant’s services rendered during the first and last months shall be calculated on a pro-rata basis.

Except for the matters set forth in this Amendment, all other terms of the Agreement shall remain unchanged and in full force and effect.

In Witness Whereof, the parties hereto have duly executed this Amendment as of March 13, 2006.


CONSULTANT	SOMAXON PHARMACEUTICALS, INC.

/s/ Terrell A. Cobb	By:	/s/ Kenneth M. Cohen

Terrell A. Cobb		Name: Kenneth M. Cohen
		Title: President and Chief Executive Officer