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VIVUS, Inc. (Nasdaq: VVUS) proclaimed electropositive results from a stage 2 cogitation evaluating the safe and efficaciousness of Qnexa®, an investigational dose, for the discourse of impeding quietus apnea (OSA). VIVUS lately realized form 3 growing of Qnexa for the discussion of fleshiness and submitted a New Drug Application (NDA) to the FDA for that reading. The work proclaimed demonstrated statistically substantial betterment in the apnea/hypopnea exponent (”AHI” - a quantity of the inclemency of sopor apnea) in patients with OSA toughened with Qnexa for 28 weeks. Qnexa-treated patients too experient meaning slant release, improvements in origin imperativeness, and nightlong bloodline o levels. OSA is a sleep-related ventilation perturb that involves a decrement or nail stoppage in airflow scorn an on-going sweat to suspire. OSA is associated with an increased danger of hypertension , diabetes , shot , sudden cardiac last and all-cause deathrate. Approximately 18 gazillion Americans sustain kip apnea.

“Obstructive rest apnea is a dangerous precondition with recognised cardiovascular and metabolous consequences, including untimely last. Current intervention approaches are circumscribed to devices or operation,” declared Leland Wilson, boss administrator policeman of VIVUS. “We acknowledge that solid burthen going can importantly amend sopor apnea. These form 2 information advise that Qnexa, if sanctioned for this indicant, may be a hopeful discourse for OSA. We bear submitted the cogitation results for display at a scientific encounter. We likewise flavor forward-moving to merging with the FDA to discourse the results of this discipline and to set the regulative itinerary for approving.”

Currently, thither are no sanctioned pharmacological treatments for OSA.

The apnea/hypopnea forefinger is the criterion bill of OSA rigour, indicating the figure of apnea/hypopnea events per hr of slumber. The form 2 sketch (OB-204) was a single-center, randomised, double-blind, placebo-controlled analogue aggroup run including 45 weighty men and women (BMI 30 to 40 kg/m2, inclusive), 30 to 65 years of age. Patients enrolled were diagnosed with OSA based on an AHI greater than or be to 15 (chair to life-threatening) at baseline. In summation to receiving dynamic or placebo dose, all patients were provided with an intensifier life-style alteration plan.

Highlights of the bailiwick admit:

– Patients tempered with Qnexa for 28 weeks had a 69% step-down in quietus apnea events

– Qnexa intervention rock-bottom the issue of apnea/hypopnea events from a signify of 46 events per hr of kip to 14 — compared to placebo patients with a diminution from a signify 44 events per minute of nap to 27 (ITT-LOCF p less than or equalize to 0.001 combat-ready vs. placebo)

– Qnexa toughened patients helpless 10.2% personify burthen , or 23.8 lbs in 28 weeks — compared to 4.3% for placebo patients, or 10.4 lbs, (ITT-LOCF p

– Systolic bloodline insistence was decreased by 15 mm Hg in the Qnexa radical from a imply of 138 mm Hg at baseline (ITT-LOCF p

– Mean nightlong o chroma was importantly improved in Qnexa patients (p

– Qnexa intervention was well-tolerated with no severe contrary events reported in the Qnexa arm; the nigh park side-effects were dry sass, neutered predilection and fistula contagion

“People oftentimes underreckoning the extent and meaning of impeding nap apnea, and the potentially lethal effects it can get for those who sustain from insistent surcease of ventilation during rest. Appropriate diagnosing and discussion of OSA, which is associated with a sixfold addition in deathrate, is decisive for patients to dilute their jeopardy,” declared David Winslow, MD, chairwoman, Kentucky Research Group, Chest Medicine Associates, P.S.C., Louisville and the work’s master tec. “These overconfident Qnexa information are supporting, as thither are presently no dose treatments usable for the status. Having a prophylactic and efficient unwritten pharmacological therapy uncommitted to dainty OSA would be a receive accession for patients.”

Sleep apnea is one of the star co-morbidities associated with corpulency and search has shown that angle expiration can meliorate OSA. Qnexa may ameliorate OSA done over-the-counter mechanisms in gain to burthen deprivation. Additional studies are aforethought to limit those mechanisms.

These information adopt the December 2009 compliance of our new dose coating to the U.S. Food and Drug Administration for Qnexa for the discourse of fleshiness, including burden exit and sustentation of burthen release, in patients who are corpulent or stoutness with co-morbidities such as hypertension, typewrite 2 diabetes, dyslipidemia or exchange adiposeness. In September 2009, VIVUS proclaimed the successful closing of the form 3 programme for Qnexa, including the latterly proclaimed results from the two polar, year-long form 3 studies, EQUIP and CONQUER. In these trials, patients toughened with all ternary doses of Qnexa achieved meaning pct and categoric burden passing compared to placebo and met regulative requirements for burthen passing products as outlined in the stream FDA Guidance for Developing Products for Weight Management. Patients tempered with Qnexa besides had important dose-related improvements in a diversity of subaltern endpoints including reductions in cardiovascular and metabolous endangerment factors.

This stage 2 bailiwick (OB-204) was a single-center, randomised, double-blind, placebo-controlled duplicate grouping tribulation including 45 weighty men and women (BMI 30 to 40 kg/m2 inclusive), 30 to 65 years of age with OSA (AHI greater than or match to 15 at baseline), who had not been hardened with, or who were not compliant with uninterrupted convinced skyway insistence (CPAP) inside trey months of showing. Patients were randomised to placebo or full-dose Qnexa. Patients underwent a four-week superman titration followed by 24 weeks of extra intervention. All patients were too provided with an intensifier life-style alteration broadcast centering on dieting and recitation. Overnight polysomnography was performed at baseline, Week 8 and Week 28. The main terminus was the alteration in AHI betwixt baseline and Week 28; lower-ranking endpoints included burden going, o intensity and changes in line insistence.

Obstructive nap apnea (OSA) is a sleep-related respiration perturb that involves a decrement or concluded freeze in airflow disdain an on-going feat to suspire. It is a vernacular yet grievous disorderliness characterized by recurrent pauses in eupnoeic during the slumber cps. Approximately 18 meg Americans are impaired with OSA, though an estimated 90% of patients stay undiagnosed or untreated. Studies suffer identified a causal kinship betwixt OSA and a act of cardiovascular and metabolous diseases including hypertension, diabetes, diagonal, congestive spirit nonstarter and sudden cardiac demise. Patient complaisance can be an issuing in treating OSA and can limitation the effectuality of presently usable treatments which admit life-style changes, uninterrupted cocksure airline force (CPAP) devices and operation.

Qnexa (Q-NEX-uh) is an investigational dose organism highly-developed to speech angle passing, typecast 2 diabetes and impeding quietus apnea. Qnexa is a once-a-day, proprietorship, unwritten, controlled-release preparation of low superman phentermine and topiramate, which is believed to reference both appetence and satiation - the two principal mechanisms that hob feeding behaviour - in one capsulise. In form 2 and 3 clinical information to escort, Qnexa has demonstrated pregnant weighting deprivation, glycemic controller, and melioration in cardiovascular danger factors.

VIVUS is a biopharmaceutical party development groundbreaking, next-generation therapies to destination unmet necessarily in fleshiness, diabetes and intimate wellness. The companionship’s tether merchandise in clinical growing, Qnexa®, has accomplished stage 3 clinical trials for the discourse of corpulency and an NDA was submitted to the FDA in December 2009. Qnexa is too in form 2 clinical developing for the handling of eccentric 2 diabetes and impeding sopor apnea. In the arena of intimate wellness, VIVUS is in form 3 growing with avanafil, a potentially best-in-class PDE5 inhibitor for the intervention of cavernous disfunction , and in form 2 developing of Luramist(TM) for the discourse of underactive intimate want upset (HSDD) in women. MUSE® (alprostadil), a outset contemporaries therapy for the handling of ED, is already on the commercialize and generating gross for VIVUS.

Certain statements in this wardrobe dismission are modern inside the signification of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of innovative run-in such as “foretell,” “trust,” “reckon,” “estimated” and “destine,” among others. These modern statements are based on VIVUS’ stream expectations and literal results could dissent materially. There are a act of factors that could causa literal events to disagree materially from those indicated by such encyclopaedia are not circumscribed to, strong contest; uncertainties of apparent tribute and litigation; uncertainties of governing or one-third company remunerator reimbursement; trust on exclusive seed suppliers; modified sales and merchandising efforts and habituation upon tierce parties; risks related to the growing of forward-looking products; and risks related to loser to receive FDA clearances or approvals and disobedience with FDA regulations. As with any pharmaceutic nether growing, thither are substantial risks in the exploitation, regulative commendation and commercialisation of new products. There are no guarantees that futurity clinical studies discussed in this crush freeing testament be realized or successful or that any merchandise leave welcome regulative blessing for any indicant or shew to be commercially successful. VIVUS does not attempt an responsibility to update or revision any innovative affirmation. Investors should interpret the endangerment factors set off in VIVUS’ Form 10-K for the year over December 31, 2008 and periodical reports filed with the Securities and Exchange Commission.

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