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): June 15, 2011

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.)

3570 Carmel Mountain Road, Suite 100, San Diego, CA	92130
(Address of Principal Executive Offices)	(Zip Code)

Registrant’s telephone number, including area code: (858) 876-6500

(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:

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

     The information attached as Exhibit 99.1 to this report relating to presentations of data from the clinical trial program for Somaxon Pharmaceuticals, Inc.’s (“Somaxon”) product Silenor® (doxepin) 3mg and 6mg tablets will be presented at the Associated Professional Sleep Societies 25^th Annual Meeting in Minneapolis, Minnesota on June 15, 2011 (the “Meeting”). The information contained in Exhibit 99.1 to this report may also be presented from time to time by Somaxon at various scientific, investor and analyst meetings after the Meeting.

     The information in this Current Report on Form 8-K, including the information 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 herein 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 in this report that are not a description of historical facts are forward-looking statements. For example, statements regarding the clinical data relating to Silenor, and Somaxon’s interpretation of such data, 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 in this release due to the risks and uncertainties inherent in Somaxon’s business, including, without limitation, inadequate therapeutic efficacy or unexpected adverse side effects relating to Silenor that could result in recalls or product liability claims; other difficulties or delays in development, testing, manufacturing and marketing of Silenor; the timing and results of post-approval regulatory requirements for Silenor, and the FDA’s agreement with Somaxon’s interpretation of such results; the market potential for insomnia treatments, and Somaxon’s ability to compete within that market; the scope, validity and duration of patent protection and other intellectual property rights for Silenor; whether the approved label for Silenor is sufficiently consistent with such patent protection to provide exclusivity for Silenor; Somaxon’s ability to successfully commercialize Silenor; Somaxon’s ability to successfully enforce its intellectual property rights and defend its patents, including any developments relating to the recent submission of abbreviated new drug applications for generic versions of Silenor 3 mg and 6 mg tablets and related patent litigation; the possible introduction of generic competition of Silenor; Somaxon’s ability to raise sufficient capital to fund its operations, and the impact of any such financing activity on the level of its stock price; the impact of any inability to raise sufficient capital to fund ongoing operations, including any patent infringement litigation; Somaxon’s ability to operate its business without infringing the intellectual property rights of others; and other risks detailed in Somaxon’s periodic filings with the Securities and Exchange Commission.

Readers 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 Securities Exchange Act of 1934.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Somaxon Clinical Data Slide Presentation — dated June 15, 2011

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: June 15, 2011
	By:	/s/ Matthew W. Onaitis
	Name:	Matthew W. Onaitis
	Title:	Senior Vice President and General Counsel

EXHIBIT INDEX

Exhibit No.	Description
99.1	Somaxon Clinical Data Slide Presentation — dated June 15, 2011

EX-99.1

Exhibit 99.1

Patient-Reported Symptom Improvement in Sleep Maintenance Endpoints in Adult and Elderly Patients with Insomnia Treated with Doxepin 3 mg and 6 mg Alan Lankford, Andrew Krystal, Brian Dorsey, Roberta Rogowski, Elizabeth Ludington, H. Heith Durrence, Charles S. Davis, Thomas Roth Support for this study provided by Somaxon Pharmaceuticals, Inc.

Introduction The most frequent complaint of insomnia patients is sleep maintenance Defined as the inability to stay asleep throughout the night or the propensity for early morning awakenings Prevalence rates are over 70%1,2 Several well-established methods are available for assessing sleep Includes questionnaires, sleep diaries, polysomnography (PSG), and actigraphy Assessments broadly divided into two categories Objective (PSG is most often used) Subjective (patient-reported) 1Lichstein et al. Epidemiology of sleep...2004. Erlbaum 2Breslau et al. Sleep disturbance...Psychiatry 2004;39:411-8

Mechanism of Action and Previous Results Sleep promoting effects of low dose doxepin (DXP) are likely mediated through histaminergic system DXP, at doses of 3 mg and 6 mg, is a highly potent and selective histamine receptor antagonist DXP at doses of 3 mg and 6 mg has demonstrated consistent efficacy in treating objective sleep maintenance1-4 1Krystal et al. Long-term Efficacy and Safety of DXP 1 mg and 3 mg...Sleep 2010;33:1553-1561 2Krystal et al. Efficacy and Safety of DXP 3 and 6 mg.... Sleep; In Press 3Segal et al. Efficacy and Safety of DXP 6 APA's 161st Meeting; 2008. Abstract NR6-091. 4Roth et al. Efficacy and Safety of DXP 6 mg... Sleep Medicine 2010;11:843-847

Study Designs Subjective data from two double-blind placebo-controlled trials are reported Study A: 12-week trial of elderly patients with chronic primary insomnia N=240; DXP 1 mg and 3 mg versus placebo (PBO) Study B: 5-week trial of adult patients with chronic primary insomnia N=221; DXP 3 mg and 6 mg versus PBO Subjective endpoints included subjective wake after sleep onset (sWASO) and subjective total sleep time (sTST) Endpoints obtained from morning questionnaire completed the morning after a night spent in the sleep laboratory Interactive Voice Response System (IVRS) was also used to collect patient data at home

Study Design Schematics, Study A Note. Study A is Elderly 12 week trial

Study Design Schematics, Study B Note. Study B is Adult 5 week trial

Data Analyses These post-hoc efficacy analyses were performed on ITT data set Included all randomized patients who received at least one dose of double-blind study drug sTST and sWASO were analyzed with mixed-effect model repeated measures (MMRM) approach MMRM methods are used to analyze all available data across time Avoids need to impute missing data Accounts for within subject variability Model included fixed effects for treatment group, time, treatment-by-time interaction, and baseline value

Corresponding Objective Results DXP 3 mg and 6 mg significantly improved PSG sleep maintenance and sleep duration in both Phase 3 trials Significant improvements in WASO and TST on Night 1 (p<0.0001) that were maintained at final time points Improvements in PSG-defined TST ranged from 25-43 minutes better than PBO

Overall Results from MMRM Analyses No interaction tests were significant None approached significance (all p-values exceeded 0.5) Results indicate no evidence that the effect of DXP 3 mg or 6 mg varied substantially over time Estimated treatment differences were significant for both sWASO and sTST and at both doses Estimated overall treatment differences were significant

Summary of MMRM Results Population Measure Dose Difference vs PBO (minutes) p-value Study A sWASO DXP 3 mg -18.3 (6.49) 0.0052 Study A sTST DXP 3 mg 18.9 (7.41) 0.0114 Study B sWASO DXP 3 mg -10.2 (4.41) 0.0213 Study B sWASO DXP 6 mg -14.2 (4.41) 0.0014 Study B sTST DXP 3 mg 11.9 (5.97) 0.0469 Study B sTST DXP 6 mg 17.3 (5.96) 0.0042 Note. The overall treatment effect across time points is displayed; estimated differences reflect estimated least squares (LS) means (standard error).

Mean Differences of DXP 3 mg from PBO for sWASO in Study A Minutes (LS mean) Note. sWASO data reflect improvement vs placebo, sWASO values are reduced vs placebo; error bars reflect standard error.

Mean Differences of DXP 3 mg from PBO for sTST in Study A Minutes (LS mean) Note. Error bars reflect standard error.

Mean Differences of DXP 3 mg and 6 mg from Placebo for sWASO in Study B Minutes (LS mean) Note. Data reflect the LS mean difference from placebo based on the average across two nights; sWASO data reflect improvement vs placebo, sWASO values are reduced vs placebo; error bars reflect standard error

Mean Differences of DXP 3 mg and 6 mg from Placebo for sWASO in Study B Minutes (LS mean) Note. Data reflect the LS mean difference from placebo based on the average across two nights; error bars reflect standard error.

Study B Study B Study B Study A Study A PBO 3 mg 6 mg PBO 3 mg OVERALL 27% 35% 32% 52% 38% Central Nervous System 14% 12% 12% 20% 11% Headache 10% 5% 0% 14% 6% Somnolence/Sedation 5% 9% 8% 5% 3% Dizziness 1% 0% 0% 2% 2% Memory Impairment 0% 0% 0% 1% 0% Gastrointestinal 4% 4% 8% 12% 6% Respiratory 3% 1% 1% 6% 5% Psychiatric 1% 1% 3% 1% 2% Other Events of Interest Dry Mouth 0% 0% 0% 2% 2% Increased Appetite 0% 0% 0% 0% 0% Summary of Adverse Events in Study B and A Note. Adverse events listed do not include all events seen in these trials.

Results Summary In these two Phase 3 trials, DXP 3 mg and 6 mg: Demonstrated early and sustained benefit on subjective measures Estimated treatment differences significant for sWASO and sTST Treatment effects did not differ across time Had consistent sleep maintenance efficacy Subjective data paralleled improvements in both objective endpoints and the IVRS data Had no evidence of residual effects in either trial (data not shown) Were well-tolerated Rates of somnolence/sedation, although higher in the DXP groups in Study B, were reported by <10% in both studies

Conclusion DXP 3 mg and 6 mg produced significant and sustained subjective improvements Improvements observed in both sleep maintenance and sleep duration endpoints Data paralleled improvements in objective endpoints Provides further evidence of DXP 3 mg and 6 mg efficacy for treating sleep maintenance insomnia Improvements did not come at expense of safety No evidence of residual sedation in either trial No evidence of rebound insomnia or other discontinuation effects (Study B; data not shown)