8-K

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 8, 2009

SOMAXON PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware	000-51665	20-0161599
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

420 Stevens Avenue, Suite 210, Solana Beach, California	92075
(Address of Principal Executive Offices)	(Zip Code)

Registrant’s telephone number, including area code: (858) 480-0400

(Former Name or Former Address, if Changed Since Last Report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01. Regulation FD Disclosure

          Richard W. Pascoe, President and Chief Executive Officer of Somaxon Pharmaceuticals, Inc., and other executive officers will be presenting the information attached as Exhibit 99.1 to this report at various investor and analyst meetings, including at the Rodman & Renshaw Annual Healthcare Conference in New York City on September 10, 2009.

          The information in this Current Report on Form 8-K, including the slides attached hereto as Exhibit 99.1, is being furnished pursuant to this Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.

          By filing this Current Report on Form 8-K and furnishing this information, Somaxon makes no admission as to the materiality of any information in this report. The information contained in the slides is summary information that is intended to be considered in the context of Somaxon’s filings with the SEC and other public announcements that Somaxon makes, by press release or otherwise, from time to time. Somaxon undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.

          Somaxon cautions you that statements included herein that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Somaxon that any of its plans will be achieved. Actual results may differ materially from those set forth herein due to the risks and uncertainties inherent in Somaxon’s business including, without limitation: Somaxon’s interpretation of its communications and interactions with the FDA relating to the requirements for approval of the NDA for Silenor, and the FDA’s agreement with such interpretation; Somaxon’s interpretation of the results of its clinical trials for Silenor, the timing of the interpretation of such results and the FDA’s agreement with such interpretation; the potential for Silenor to receive regulatory approval for one or more indications on a timely basis or at all; the potential for the FDA to impose non-clinical, clinical or other requirements to be completed before or after regulatory approval of Silenor; Somaxon’s ability to demonstrate to the satisfaction of the FDA that potential NDA approval of Silenor is appropriate prior to the completion of standard, long-term carcinogenicity studies, given the context of completed trials and pending studies; the timing and results of non-clinical studies for Silenor, and the FDA’s agreement with Somaxon’s interpretation of such results; Somaxon’s ability to raise sufficient capital to meet FDA requirements and otherwise fund its operations, and to meet its obligations to parties with whom it contracts relating to financing activity, and the impact of any such financing activity on the level of Somaxon’s stock price; the impact of any inability to raise sufficient capital to fund ongoing operations, including the potential to be required to restructure the company or to be unable to continue as a going concern; Somaxon’s ability to successfully commercialize Silenor, if it is approved by the FDA; the potential to enter into and the terms of any strategic transaction relating to Silenor; the scope, validity and duration of patent protection and other intellectual property rights for Silenor; whether any approved label for Silenor is sufficiently consistent with such patent protection to provide exclusivity for Silenor; Somaxon’s ability to operate its business without infringing the intellectual property rights of others; inadequate therapeutic efficacy or unexpected adverse side effects relating to Silenor that could delay or prevent regulatory approval or commercialization, or that could result in recalls or product liability claims; other difficulties or delays in development, testing, manufacturing and marketing of and obtaining regulatory approval for Silenor; the market potential for insomnia treatments, and Somaxon’s ability to compete within that market; and other risks detailed in Somaxon’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other periodic filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Somaxon undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Exchange Act.

Item 9.01. Financial Statements and Exhibits

     (d) Exhibits.

Exhibit No.	Description
99.1	Company Update Slides — dated September 10, 2009.

SIGNATURES

     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	SOMAXON PHARMACEUTICALS, INC.
Date: September 8, 2009
	By:	/s/ Matthew W. Onaitis
	Name:	Matthew W. Onaitis
	Title:	Vice President and General Counsel

EXHIBIT INDEX

Exhibit No.	Description
99.1	Company Update Slides — dated September 10, 2009.

EX-99.1

Exhibit 99.1

Somaxon Pharmaceuticals, Inc. September 10, 2009 Rodman & Renshaw 11th Annual Healthcare Conference Nasdaq: SOMX

Forward Looking Statements This presentation contains forward-looking statements about our business, including results of our clinical trials, potential regulatory approval for our product candidate, development timelines, future financial results and events that have not yet occurred. Pharmaceutical development inherently involves significant risks and uncertainties, including the risks outlined under "Risk Factors" and elsewhere in our Annual Report on Form 10-K and our other filings made with the SEC from time to time. Our actual results may differ materially from our expectations due to these risks and uncertainties, including our near-term dependence on the success of our lead product candidate, Silenor(r), and factors relating to regulatory approval, research and development, intellectual property protection, ability to raise sufficient capital, ability to attract a strategic partner, competition, industry environment, and other matters. Somaxon undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

Corporate Strategy Develop and Commercialize Highly Differentiated Products Focus on late stage or currently marketed assets to reduce development risk Address unmet medical need and patient dissatisfaction in established markets Leverage development, regulatory and commercial expertise Deploy a US Commercial Organization Focus on the CNS therapeutic area Cover high-prescribing physicians with a targeted sales force Create efficiencies through strategic outsourcing Establish Commercial Collaborations to Drive Growth and Profitability Effectively leverage partner resources Reach broader PCP prescriber universe Attract additional product opportunities

Silenor(r) Profile Near-term Opportunity NDA under review "Launch Ready" Marketing Campaign Product profile supports attractive revenue estimates Differentiated Mechanism of Action H1 v. GABA or Melatonin Strong Clinical Efficacy Profile Primary efficacy endpoint significant for all Phase 3 studies Maintenance into the 8th hour of the night Favorable Safety and Tolerability Profile Not scheduled Adverse events comparable to placebo No GABA-ergic related side effects Large Yet Accessible Insomnia Market Over 64MM TRx's in US 44,000 prescribers write half of all TRx's Changing insomnia market dynamics = commercial upside

Significant Events Silenor NDA Initial PDUFA date 12/01/08 Agency delay - New PDUFA date 02/28/09 Complete Response letter 02/25/09 NDA re-submission 06/04/09 New PDUFA date 12/04/09 Strengthened Balance Sheet Sold non-strategic asset to Lundbeck for $1MM in 1Q 2009 Closed on $6MM PIPE on 07/08/09 Cash runway through 2Q 2010 Included existing and new investors

Insomnia Market

Insomnia Market Overview The U.S. insomnia market is large and growing 70 million people in the U.S. suffer from insomnia The market remains under-diagnosed, under-treated, and dissatisfied 14 million (20%) are currently on Rx treatment 9 million currently on Rx treatment (67%) claim they are not satisfied with their current treatment 56 million utilize OTC and other remedies Current treatment options have forced physicians and patients to accept compromise GABA-ergic drugs provide efficacy to varying degrees but involve compromise on tolerability and risk of addiction OTCs address addiction concerns but involve compromise on efficacy and tolerability Melatonin-receptor antagonists address addiction and tolerability concerns but involve compromise on efficacy

2004 2005 2006 2007 2008 Ambien 44 47 54 59 64 Continued Growth in the Insomnia Market Total Rx Millions Total Prescriptions Source: IMS 6% YOY Growth 11/08

6.4 12.8 19.2 25.6 32 Rxs per Decile 6.4 12.8 19.2 25.6 32 Accessible Market Source: IMS Health 44,000 Prescribers Write Half of all TRx's 44,458 30,432 19,235 10,454 3,905 Cumulative # of MDs per decile 10 9 8 7 6 (Decile) (# Rxs)

Changing Market Dynamics "Window of Opportunity" for new treatments No new compounds for the treatment of insomnia have been launched since 2006 No new "novel" compounds expected to launch in near term Number of primary details is decreasing Recent sales force reductions Competitive brands lack a differentiated message Promotional spending is decreasing DTC spending down 44% year over year Consistent trend across brands

Market Remains Dissatisfied Poorly/Not at All Controlled Completely/Well Controlled Somewhat Controlled 4th Qtr East 39 12 49 20.4 West 30.6 38.6 34.6 31.6 North 45.9 46.9 45 43.9 Somaxon Market Research, 2006 n = 451 "How well would you say your insomnia/sleep problem is controlled?" 12% 39% 49%

Sleep Maintenance Issues Remain Any Sleep Problem 0.35 0.65 65% 35% Sleep Problem in Past Month At Least a Few Nights/Week 49% Woke Unrefreshed 42% Frequent Nocturnal Awakenings 29% Early Morning Awakenings 26% Difficulty Falling Asleep National Sleep Foundation. Summary of findings: 2008 Sleep in America poll. n = 1760 respondents

A Novel Treatment for Insomnia Silenor (r)

Differentiated Mechanism of Action Histamine (H1) is one of several waking neuro- transmitters important in the arousal system Silenor has high affinity for H1 receptors Silenor has significant effects at night through the blockade of H1, which promotes and maintains sleep H1 blockade does not prevent or diminish arousal due to other neurotransmitters in the arousal system

Relative Affinity for H1 Receptors 1 2,500 5,000 7,500 10,000 Doxepin Amitriptyline* Trazodone Diphenhydramine Inverse Affinity (1/Kd (nM) x 10,000) 1,000 10,000 488 16 *Preskorn SH, et al. J Psychiatr Pract. 2003;9(5):376-384. Mansbach RS. Poster presented at: 21st European College of Neuropsychopharmacology Congress; August 30-September 3, 2008; Barcelona, Spain.

Doxepin Receptor Affinity H1 5HTT NET M1 alpha 1 5HT2A 433 649 134 82 10,000 709 1 1000 2500 5,000 10,000 100,000 Inverse Selectivity (1/Selectivity) x 10,000 Mansbach RS. Poster presented at: 21st European College of Neuropsychopharmacology Congress; August 30-September 3, 2008; Barcelona, Spain.

Silenor Clinical Program Phase 3 Studies Patients Enrolled Completed SP-501- 35 day Adult CI -PSG-3mg & 6mg n= 229 2nd Qtr 2006 SP-502 - Adult TI-PSG- 6mg n=565 3rd Qtr 2006 SP-503 -3 Month Elderly PSG- 1mg & 3mg n=240 4th Qtr 2006 SP-509 - 4 week Elderly Out Patient - 6mg n=255 4th Qtr 2006 Phase 2 Studies SP-401 Adult PSG 1mg, 3mg & 6mg n=67 4th Qtr 2004 SP-402 Elderly PSG 1mg,3mg &6mg n=76 4th Qtr 2004 Phase 1 Studies SP-405 Dose Linearity n=16 1st Qtr 2006 SP-504 Food Effect n=16 1st Qtr 2006 SP-506 Zoloft (SSRI) n=24 2st Qtr 2006 SP-505 Cimetidine (2D6) n=24 2st Qtr 2006 SP-507 Relative BA n=24 2st Qtr 2006 SP-801 Cardiac n=206 4th Qtr 2008

Silenor Clinical Data Summary ONSET ONSET MAINTENANCE MAINTENANCE MAINTENANCE MAINTENANCE PREVENT EARLY AWAKENINGS PREVENT EARLY AWAKENINGS GLOBAL OUTCOMES GLOBAL OUTCOMES Study Dose LPS LSO WASO sWASO TST sTST WTAS SE hr 8 CGI PGI P2 Adult 1 mg P2 Adult 3 mg P2 Adult 6 mg P2 Elderly 1 mg P2 Elderly 3 mg P2 Elderly 6 mg P3 Adult 3 mg P3 Adult 6 mg P3 Transient 6 mg P3 Elderly 1 mg P3 Elderly 3 mg P3 Elderly 6 mg KEY: = p<0.05; p>0.05; Not Assessed Primary Endpoint ? ? ? ? ? ? ?

Phase 3 Adult Long-term Trial: WASO Night 1 and Night 29 <0.0001 0.0299 p-value 3 mg: 6 mg: Night 1 Night 29 PBO 67 62 DXP 3 mg 41 47 DXP 6 mg 36 41 <0.0001 0.0012 DXP 3 mg PBO DXP 6 mg Minutes (mean)

PBO DXP 1mg DXP 3mg 0 1 0.505 0.62 0.606 2 0.783 0.901 0.914 3 0.848 0.933 0.93 4 0.861 0.909 0.932 5 0.829 0.898 0.901 6 0.807 0.894 0.93 7 0.852 0.888 0.912 8 0.745 0.878 0.884 Ovrl 0.71 0.75 0.8 Phase 3 Adult Long-term Trial: Sleep Efficiency by Hour p-value 3 mg 6 mg 0.3916 0.0492 <0.0001 <0.0001 0.0671 0.1040 0.0014 0.0001 0.0002 0.0006 0.0650 0.0020 0.0693 0.0282 0.0063 <0.0001 DXP 3 mg PBO DXP 6 mg

Phase 3 Transient Insomnia Trial: LPS PBO DXP 6 mg ITT 33.6 20.6 p< 0.0001 Minutes (mean)

Elderly Long-term Trial: Patient Global Impressions After 12 Weeks % of Subjects Reporting Yes Helped Sleep Shortened Onset Increased Duration Got Better Sleep Drug Strength Just Right PBO 0.41 0.37 0.36 0.4 0.29 DXP 1 mg 0.72 0.55 0.58 0.67 0.51 DXP 3 mg 0.74 0.64 0.68 0.74 0.54 * * * * * * * * * * DXP 3 mg DXP 1 mg PBO * p<0.05, vs PBO

Incidence (%) of Treatment-Emergent Adverse Events in Long-term Placebo-Controlled Clinical Trials System Organ Class Preferred Term* Placebo (N=278) Silenor 1 mg (N=77) Silenor 3 mg (N=157) Silenor 6 mg (N=203) Nervous System Disorders Somnolence 4 5 6 9 Infections and Infestations Upper Respiratory Tract Infection 1 3 2 2 Nasopharyngitis 1 1 2 < 1 Sinusitis < 1 4 0 < 1 Urinary Tract Infection 1 3 0 < 1 Gastroenteritis 0 0 2 0 Gastrointestinal Disorders Nausea 1 0 2 2 Vascular Disorders Hypertension 0 1 3 < 1 * Includes events that occurred at a rate of ? 2% in any Silenor-treated group and at a higher rate than placebo. Preferred terms of somnolence and sedation were combined as somnolence. Events for which the Silenor incidence was ? 2% and equal to or less than placebo are not listed on the table, but included the following: headache, diarrhea. * Includes events that occurred at a rate of ? 2% in any Silenor-treated group and at a higher rate than placebo. Preferred terms of somnolence and sedation were combined as somnolence. Events for which the Silenor incidence was ? 2% and equal to or less than placebo are not listed on the table, but included the following: headache, diarrhea. * Includes events that occurred at a rate of ? 2% in any Silenor-treated group and at a higher rate than placebo. Preferred terms of somnolence and sedation were combined as somnolence. Events for which the Silenor incidence was ? 2% and equal to or less than placebo are not listed on the table, but included th e following: headache, diarrhea. * Includes events that occurred at a rate of ? 2% in any Silenor-treated group and at a higher rate than placebo. Preferred terms of somnolence and sedation were combined as somnolence. Events for which the Silenor incidence was ? 2% and equal to or less than placebo are not listed on the table, but included the following: headache, diarrhea. * Includes events that occurred at a rate of ? 2% in any Silenor-treated group and at a higher rate than placebo. Preferred terms of somnolence and sedation were combined as somnolence. Events for which the Silenor incidence was ? 2% and equal to or less than placebo are not listed on the table, but included the following: headache, diarrhea.

Silenor Commercialization Silenor (r)

"Plan to Win" Capitalize on the Changing Market Dynamics Competitor "turbulence" Lack of differentiated insomnia treatments Shift from expensive DTC strategy Launch with a Competitive Share of Voice with a Partner Target high value physicians ~ 300 Reps achieves 50% coverage Utilize non-personal promotional efforts to leverage into lower deciles Exploit Silenor sampling advantage Integrated Professional Campaign Developed Strong branding elements Patient Education Programs Technology driven physician education Competitive publication plan at launch Targeted Consumer Campaign Developed "Direct to Insomniac" communication via Web Point of Care Programs/Public Relations

Silenor Strategic Platform Unique MOA Differentiate from GABA and non-selective H1's Emphasize broad clinical profile Maintenance Prevention of early awakenings Sleep onset (<30 min) Leverage safety /tolerability profile Non-scheduled Preserves sleep architecture No memory impairment Focus on end benefit to the patient Full night's sleep No next day effects Improved patient outcomes

Strategic Collaboration for Silenor GOALS Successful Silenor launch in 1H 2010 Build a focused Somaxon commercial organization Maximize shareholder value Traditional licensing with co-promotion rights Co-promotion with shared revenues and costs M&A to gain access to sales infrastructure/ products

Somaxon Pharmaceuticals, Inc. Corporate Summary

Financials Cash, cash equivalents & marketable securities (7/31/09) Shares outstanding Fully diluted shares $6.8 MM* 23.6 MM 34.9 MM * Sufficient to fund operations through 2Q 2010 based upon current operating plan

Near-Term Priorities Obtain regulatory approval for Silenor NDA re-submisssion accepted in June 12/4/09 PDUFA action date Partner Silenor Ongoing dialogue with multiple parties Build commercial infrastructure Execute post-approval Launch Silenor in US in 1H 2010

Somaxon Value Proposition Silenor Highly differentiated insomnia treatment Favorable market dynamics "Launch Ready" campaign following regulatory approval Attractive revenue potential Experienced management team Significant commercial launch experience Building a focused commercial organization Capable of driving product sales and profitability Able to leverage/support additional products

Somaxon Pharmaceuticals, Inc. Thank You!