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)

January 7, 2010

VIVUS, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-33389	94-3136179
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

1172 CASTRO STREET

MOUNTAIN VIEW, CA 94040

(Address of principal executive offices, including zip code)

(650) 934-5200

(Registrant’s telephone number, including area code)

N/A

(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):

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

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

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

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

Item 8.01.  Other Events

On January 7, 2010, VIVUS, Inc. (the “Company”) issued a press release titled “VIVUS Announces Positive Results From Phase 2 Study of Qnexa in Obstructive Sleep Apnea.”  A copy of the press release is attached hereto as Exhibit 99.1.

As previously announced, on January 7, 2010 at 8:30 a.m. Eastern Time, the Company will host a conference call and webcast discussion of the Qnexa Phase 2 results.  A copy of the Qnexa Obstructive Sleep Apnea Phase 2 Results (OB-204) slides to be presented on the conference call and included with the webcast is attached hereto as Exhibit 99.2.  The conference call information is 1-888-806-6202 for domestic callers and 1-913-312-6680 for international callers.  The webcast information is http://ir.vivus.com.

The information in this Form 8-K and the exhibits attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference into any of the Registrant’s filings under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in any such filing.

Item 9.01.  Financial Statements and Exhibits

(d)  Exhibits.

Exhibit No.	Description
99.1	Press Release dated January 7, 2010
99.2	Qnexa Obstructive Sleep Apnea Phase 2 Results (OB-204) Slide Presentation

2

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.

	VIVUS, INC.
By:	/s/ Lee B. Perry
	Lee B. Perry Vice President and Chief Accounting Officer

Date: January 7, 2010

3

EXHIBIT INDEX

Exhibit No.	Description
99.1	Press Release dated January 7, 2010
99.2	Qnexa Obstructive Sleep Apnea Phase 2 Results (OB-204) Slide Presentation

4

EX-99.1

Exhibit 99.1

CONTACT:

VIVUS, Inc.	Investor Relations:	The Trout Group
Timothy E. Morris		Brian Korb
Chief Financial Officer		646-378-2923
650-934-5200
	Media Relations:	Pure Communications, Inc.
		Dan Budwick
		973-271-6085

VIVUS ANNOUNCES POSITIVE RESULTS FROM PHASE 2 STUDY OF QNEXA IN OBSTRUCTIVE SLEEP APNEA

Qnexa Treatment Results in 69% Reduction in Sleep Apnea Events

MOUNTAIN VIEW, Calif., January 7, 2010 — VIVUS, Inc. (NASDAQ: VVUS) today announced positive results from a phase 2 study evaluating the safety and efficacy of Qnexa®, an investigational drug, for the treatment of obstructive sleep apnea (OSA). VIVUS recently completed phase 3 development of Qnexa for the treatment of obesity and submitted a New Drug Application (NDA) to the FDA for that indication.  The study announced today demonstrated statistically significant improvement in the apnea/hypopnea index (“AHI” — a measure of the severity of sleep apnea) in patients with OSA treated with Qnexa for 28 weeks.  Qnexa-treated patients also experienced significant weight loss, improvements in blood pressure, and overnight blood oxygen levels.  OSA is a sleep-related breathing disorder that involves a decrease or complete halt in airflow despite an ongoing effort to breathe.  OSA is associated with an increased risk of hypertension, diabetes, stroke, sudden cardiac death and all-cause mortality. Approximately 18 million Americans have sleep apnea.

“Obstructive sleep apnea is a serious condition with recognized cardiovascular and metabolic consequences, including premature death. Current treatment approaches are limited to devices or surgery,” stated Leland Wilson, chief executive officer of VIVUS. “We know that substantial weight loss can significantly improve sleep apnea. These phase 2 data suggest that Qnexa, if approved for this indication, may be a promising treatment for OSA. We have submitted the study results for presentation at a scientific meeting.  We also look forward to meeting with the FDA to discuss the results of this study and to determine the regulatory path for approval.”

Currently, there ar e no approved pharmacologic treatments for OSA.

The apnea/hypopnea index is the standard measure of OSA severity, indicating the number of apnea/hypopnea events per hour of sleep. The phase 2 study (OB-204) was a single-center, randomized, double-blind, placebo-controlled parallel group trial including 45 obese men and women (BMI 30 to 40 kg/m2, inclusive), 30 to 65 years of age.  Patients enrolled were diagnosed

VIVUS, Inc. 1172 Castro Street, Mountain View, CA 94040   Tel 650-934-5200   Fax 650-934-5389  www.vivus.com

with OSA based on an AHI >15 (moderate to severe) at baseline.  In addition to receiving active or placebo drug, all patients were provided with an intensive lifestyle modification program.

Highlights of the study include:

·Patients treated with Qnexa for 28 weeks had a 69% reduction in sleep apnea events

·Qnexa treatment reduced the number of apnea/hypopnea events from a mean of 46 events per hour of sleep to 14 —compared to placebo patients with a reduction from a mean 44 events per hour of sleep to 27 (ITT-LOCF p<0.001 active vs. placebo)

·Qnexa treated patients lost 10.2% body weight, or 23.8 lbs in 28 weeks — compared to 4.3% for placebo patients, or 10.4 lbs,  (ITT-LOCF p<0.001 active vs. placebo)

·Systolic blood pressure was reduced by 15 mm Hg in the Qnexa group from a mean of 138 mm Hg at baseline (ITT-LOCF p<0.04 active vs. placebo)

·Mean overnight oxygen saturation was significantly improved in Qnexa patients (p<0.014 active vs. placebo)

·Qnexa treatment was well-tolerated with no serious adverse events reported in the Qnexa arm; the most common side-effects were dry mouth, altered taste and sinus infection

“People often underestimate the extent and significance of obstructive sleep apnea, and the potentially deadly effects it can have for those who suffer from repetitive cessation of breathing during sleep. Appropriate diagnosis and treatment of OSA, which is associated with a six-fold increase in mortality, is critical for patients to reduce their risk,” stated David Winslow, MD, president, Kentucky Research Group, Chest Medicine Associates, P.S.C., Louisville and the study’s primary investigator. “These positive Qnexa data are encouraging, as there are currently no drug treatments available for the condition. Having a safe and effective oral pharmacologic therapy available to treat OSA would be a welcome addition for patients.”

Sleep apnea is one of the leading co-morbidities associated with obesity and research has shown that weight loss can improve OSA. Qnexa may improve OSA through other mechanisms in addition to weight loss. Additional studies are planned to define those mechanisms.

These data follow the December 2009 submission of our new drug application to the U.S. Food and Drug Administration for Qnexa for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia or central adiposity. In September 2009, VIVUS announced the successful completion of the phase 3 program for Qnexa, including the recently announced results from the two pivotal, year-long phase 3 studies, EQUIP and CONQUER. In these trials, patients treated with all three doses of Qnexa achieved significant percent and categorical weight loss compared to placebo and met regulatory requirements for weight loss products as defined in the current FDA Guidance for Developing Products for Weight Management. Patients treated with Qnexa also had significant dose-related improvements in a variety of secondary endpoints including reductions in cardiovascular and metabolic risk factors.

About the OB-204 Study

This phase 2 study (OB-204) was a single-center, randomized, double-blind, placebo-controlled parallel group trial including 45 obese men and women (BMI 30 to 40 kg/m2 inclusive), 30 to 65

years of age with OSA (AHI >15 at baseline), who had not been treated with, or who were not compliant with continuous positive airway pressure (CPAP) within three months of screening. Patients were randomized to placebo or full-dose Qnexa. Patients underwent a four-week dose titration followed by 24 weeks of additional treatment. All patients were also provided with an intensive lifestyle modification program focusing on diet and exercise. Overnight polysomnography was performed at baseline, Week 8 and Week 28. The primary endpoint was the change in AHI between baseline and Week 28; secondary endpoints included weight loss, oxygen saturation and changes in blood pressure.

About Obstructive Sleep Apnea (OSA)

Obstructive sleep apnea (OSA) is a sleep-related breathing disorder that involves a decrease or complete halt in airflow despite an ongoing effort to breathe.  It is a common yet serious disorder characterized by repeated pauses in breathing during the sleep cycle. Approximately 18 million Americans are afflicted with OSA, though an estimated 90% of patients remain undiagnosed or untreated. Studies have identified a causal relationship between OSA and a number of cardiovascular and metabolic diseases including hypertension, diabetes, stroke, congestive heart failure and sudden cardiac death.  Patient compliance can be an issue in treating OSA and can limit the effectiveness of currently available treatments which include lifestyle changes, continuous positive airway pressure (CPAP) devices and surgery.

Note to Investors

As previously announced, VIVUS will hold a conference call to discuss these results today, January 7, 2010, beginning at 8:30 a.m. Eastern Time. You can listen to this call by dialing toll free 1-888-806-6202 or outside the U.S. 1-913-312-6680. A 30-day archive of the call can be accessed at http://ir.vivus.com/.

To access the webcast of this event, please visit: VIVUS’ Investors’ site at http://ir.vivus.com/events.cfm. Replay will also be available on demand from the website at the conclusion of the program.

About Qnexa

Qnexa (Q-NEX-uh) is an investigational drug being developed to address weight loss, type 2 diabetes and obstructive sleep apnea. Qnexa is a once-a-day, proprietary, oral, controlled-release formulation of low dose phentermine and topiramate, which is believed to address both appetite and satiety - the two main mechanisms that impact eating behavior - in one capsule. In phase 2 and 3 clinical data to date, Qnexa has demonstrated significant weight loss, glycemic control, and improvement in cardiovascular risk factors.

About VIVUS

VIVUS is a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health.  The company’s lead product in

clinical development, Qnexa®, has completed phase 3 clinical trials for the treatment of obesity and an NDA was submitted to the FDA in December 2009. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea.  In the area of sexual health, VIVUS is in phase 3 development with avanafil, a potentially best-in-class PDE5 inhibitor for the treatment of erectile dysfunction, and in phase 2 development of Luramist™ for the treatment of hypoactive sexual desire disorder (HSDD) in women. MUSE® (alprostadil), a first generation therapy for the treatment of ED, is already on the market and generating revenue for VIVUS. For more information about the company, please visit www.vivus.com.

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” among others. These forward-looking statements are based on VIVUS’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; reliance on sole source suppliers; limited sales and marketing efforts and dependence upon third parties; risks related to the development of innovative products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical studies discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. VIVUS does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in VIVUS’ Form 10-K for the year ended December 31, 2008 and periodic reports filed with the Securities and Exchange Commission.

###

EX-99.2

Exhibit 99.2

Qnexa Obstructive Sleep Apnea Phase 2 Results (OB-204) Qnexa

 VIVUS cautions you that statements included in this presentation that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests,“ "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on VIVUS’ current beliefs and expectations. These forward-looking statements include statements regarding the efficacy and safety of Qnexa, the potential for, and timing of, any NDA submission for Qnexa, the commercial and therapeutic potential of Qnexa, and the potential to obtain regulatory approval for, and effectively treat obstructive sleep apnea (OSA) with, Qnexa. The inclusion of forward looking statements should not be regarded as a representation by VIVUS that any of its plans will be achieved. Actual results may differ from those set forth in this presentation due to the risk and uncertainties inherent in VIVUS’ business, including, without limitation: additional analyses of data from the Qnexa Phase 3 obesity trials, the results of this single center study in OSA and any other clinical trials of Qnexa may produce negative or inconclusive results, or may be inconsistent with previously announced results or previously conducted clinical trials; the FDA may not agree with VIVUS’ interpretation of efficacy and safety results; earlier clinical trials may not be predictive of future results; Qnexa may not receive regulatory approval on a timely basis or at all, and the FDA may require VIVUS to complete additional clinical, non-clinical or other requirements prior to the submission or the approval of NDAs for a product candidate; the potential for adverse safety findings relating to Qnexa to delay or prevent regulatory approval or commercialization, or result in product liability claims, including serious adverse events that are not characterized by clinical investigators as possibly related to Qnexa; the third parties on whom VIVUS relies to assist with the development programs for Qnexa, including clinical investigators, contract laboratories, clinical research organizations and manufacturing organizations, may not successfully carry out their contractual duties or obligations or meet expected deadlines, and the quality or accuracy of the data or materials generated by such third parties may be of insufficient quality to include in VIVUS’ regulatory submissions; the ability of VIVUS and its licensors to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its product candidates; VIVUS may be unable to enter a collaboration or partnership relating to Qnexa for promotion to broader markets on attractive terms or at all; and other risks described in VIVUS’ filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and VIVUS undertakes no obligation to revise or update this presentation to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Information included herein is based on VIVUS’ review and evaluation of the clinical data. All conclusions and determinations contained herein are subject to VIVUS’ Qnexa analysis of the clinical data. The ultimate determination of the safety and efficacy of Qnexa will be made by the FDA and other relevant regulatory authorities. Forward-Looking Statements

Obstructive Sleep Apnea (OSA) is a Serious Unmet Medical Need Obstructive sleep apnea (OSA) is a sleep-related breathing disorder that involves a decrease or complete halt in airflow despite an ongoing effort to breathe Long term effects of OSA include hypertension, stroke and premature death1,2 Obesity is the major risk factor for development of OSA 18 million adults in the US are estimated to have sleep apnea Up to 90% of OSA patients are untreated There is currently no approved pharmacotherapy agent for OSA 1. Marshall, et al., SLEEP 2008 2. Young et al. SLEEP 2008

Sleep Apnea is a Common Condition in Co-morbid Patients 1. Einhorn et al., Endocrine Prac 2007 2. O’Keefe and Patterson, Obesity Surgery 2004 3. Maisel et al., HFSA 2007, Wash DC 4. Logan et al, J. Hypertension 2001 1 2 3 4 Percent of Patients with OSA 80% 80% 77% 72% Drug-Resistant Hypertension Congestive Heart Failure Obesity Type 2 Diabetes

OSA Diagnosis Apnea-Hypopnea Index Apnea-Hypopnea Index (AHI) is the standard measure of OSA Defined as cessation of breathing for 10 seconds or more Measured as total events per hour of sleep Scale: 0-5 Normal 5-15 Mild 15-30 Moderate >30 Severe AHI is measured in overnight stay at sleep lab using polysomnography (PSG)

Recognized Treatments for OSA Current treatments for OSA include: Weight loss Oral appliances and devices Surgery Continuous Positive Airway Pressure (CPAP) Device There is currently no approved pharmacotherapy agent for OSA

CPAP Treatment is the Current Standard of Care for OSA CPAP treats symptoms of OSA, not the cause Poor compliance with CPAP limits benefit of treatment Sales of CPAP devices exceeded $2 billion in 2008 Philips Respironics ResMed Inc.

OB-204: Phase 2 Study Design and Criteria for Entry Titration (4 weeks) Treatment (24 weeks) Overnight Stay in Sleep Lab (PSG) Placebo (n=23) 0 Week 8 Week 28 Screening (2 weeks) Screening Kentucky Research Group, Louisville, Dr. David Winslow AHI at baseline >15 (moderate or severe OSA based on polysomnography) Primary endpoint: Apnea-Hypopnea Index Secondary endpoints: weight loss, oxygen saturation, blood pressure Qnexa (n=22)

OB-204: Baseline Demographics 36 35 BMI 41 65 Gender male % 138/87 138/90 Blood Pressure Baseline 22 23 Patients (Intent-to-treat) Qnexa Placebo 235 44 51 Age 53 AHI 46 Weight (lbs) 229

OB-204: Weight Loss as a Percentage of Baseline Weight *p<0.001 active vs. placebo change from baseline * -4.3 -10.2 -12.0 -9.0 -6.0 -3.0 0.0 % Weight Loss (ITT-LOCF) Placebo Qnexa

OB-204: AHI Events Qnexa Significantly Reduces OSA Events *p<0.001 active vs. placebo change from baseline 69% (32 events per hour of sleep) reduction in OSA events after 28 weeks of treatment Qnexa patients had a near two-fold improvement in AHI as compared to placebo (32 vs. 17) ITT-LOCF * Baseline Week 28 Week 28 Baseline 46 27 14 44 0 10 20 30 40 50 Placebo Qnexa AHI Events Per Hour of Sleep

OB-204: Overnight Oxygen Saturation Qnexa Significantly Increases Blood Oxygen Saturation *p<0.014 active vs. placebo change from baseline * ITT-LOCF Normal sleeping Oxygen Saturation ~ 95% Baseline Baseline Week 28 Week 28 93.9 93.4 94.6 95.4 92 93 94 95 96 Placebo Qnexa Mean Overnight % Oxygen Saturation

OB-204: Blood Pressure Qnexa Treatment Significantly Improves SBP *p<0.04 active vs. placebo change from baseline ITT-LOCF 15 mmHg reduction in systolic blood pressure * Week 28 Week 28 Baseline Baseline 138 138 131 123 110 125 140 Placebo Qnexa SBP mmHg

OB-204: Conclusion Qnexa May be Promising Treatment for OSA Qnexa treatment for 28 weeks produced significant benefits in patients with OSA Number of apnea/hypopnea events decreased by 69% from a mean of 46 events per hour (severe) to 14 events per hour (mild) Lost 10.2% body weight or 23.8 pounds Oxygen saturation improved Systolic blood pressure decreased Most common side effects were dry mouth, altered taste, sinus infection No serious adverse events reported in Qnexa arm Data suggests that OSA is a promising new indication for Qnexa Study results submitted for presentation at scientific meeting Potential to be first pharmacotherapy for OSA