VIVUS Announces FDA Acceptance Of Qnexa(R) New Drug Application For Treatment Of Obesity
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VIVUS, Inc. (Nasdaq: VVUS) proclaimed that the U.S. Food and Drug Administration (FDA) has recognized for filing the caller’s new dose coating (NDA) for its investigational dose, Qnexa®, for the discussion of corpulency . The butt escort for the FDA to finish its follow-up of the Qnexa NDA is October 28, 2010. In antecedently proclaimed polar stage 3 trials, patients tempered with all 3 doses of Qnexa achieved substantial weightiness expiration compared to placebo, and substantial dose-related improvements in a sort of junior-grade endpoints including reductions in cardiovascular, seditious and metabolous endangerment factors.
“The FDA’s toleration of the Qnexa NDA marks an authoritative milepost in the growing of Qnexa as a discussion for patients who are weighty or heavy with co-morbidities,” declared Leland F. Wilson, foreman administrator officeholder for VIVUS. “We consider that Qnexa, if sanctioned, leave turn an crucial part in treating the millions of patients life with fleshiness and related diseases, and who are in motive of safety and efficacious options.”
The form 3 clinical broadcast, which evaluated Qnexa in more than 4,500 patients, was intentional below a Special Protocol Assessment with the U.S. FDA and consisted of iii trials: EQUATE (OB-301), EQUIP (OB-302) and CONQUER (OB-303). The EQUATE bailiwick was a 28-week randomised, double-blind, placebo-controlled, 7-arm, prospective test with patients randomised to get once-a-day intervention with mid- or full-dose Qnexa, the various phentermine and topiramate constituents, or placebo. The median baseline BMI of the discipline universe was 36.3 kg/m2 with an mean baseline burthen of 223 pounds. The EQUIP and CONQUER studies were 56-week, randomised, double-blind, placebo-controlled, 3-arm, prospective trials with patients randomised to find once-a-day intervention with low-, mid-, or full-dose Qnexa, or placebo. In EQUIP, the mean baseline BMI of the field universe was 42.1 kg/m2 with an mean baseline angle of 256 pounds; in CONQUER, the mean baseline BMI of the cogitation universe was 36.6 kg/m2 with an norm baseline angle of 227 pounds. All patients were asked to espouse a hypocaloric dieting representing a 500-calorie/day shortfall and well-advised to apply a bare life-style change broadcast.
Qnexa (Q-NEX-uh) is an investigational dose beingness highly-developed to direct angle departure. Qnexa is a once-a-day, proprietorship, viva, controlled-release conceptualisation of low acid phentermine and topiramate, which is believed to destination both appetence and satiation - the two chief mechanisms that hob feeding demeanour - in one capsulise. In stage 2 and 3 clinical information to escort, Qnexa has demonstrated meaning weightiness exit, glycemic restraint, step-down in sopor apnea events and melioration in cardiovascular jeopardy factors.
VIVUS is a biopharmaceutical party development modern, next-generation therapies to accost unmet inevitably in fleshiness, diabetes and intimate wellness. The party’s tether ware in clinical evolution, Qnexa®, has latterly realized stage 3 clinical trials for the intervention of fleshiness. Qnexa is likewise in stage 2 clinical developing for the intervention of case 2 diabetes and impeding slumber apnea (OSA). In the country of intimate wellness, VIVUS is in stage 3 maturation with avanafil, a potentially best-in-class PDE5 inhibitor, and in stage 2 growth of Luramist™ for the discussion of underactive intimate trust upset (HSDD) in women. MUSE® (alprostadil), a low coevals therapy for the handling of ED, is already on the grocery and generating gross for VIVUS.
Certain statements in this imperativeness dismissal are advanced inside the signification of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of advanced language such as “foretell,” “conceive,” “estimate,” “estimated” and “mean,” among others. These advanced statements are based on VIVUS’ stream expectations and literal results could disagree materially. There are a act of factors that could drive genuine events to disagree materially from those indicated by such encyclopedia are not express to, real rival; uncertainties of manifest tribute and litigation; uncertainties of administration or tertiary company remunerator reimbursement; trust on resole reference suppliers; modified sales and merchandising efforts and habituation upon one-third parties; risks related to the developing of groundbreaking products; and risks related to loser to get FDA clearances or approvals and disobedience with FDA regulations. As with any pharmaceutic below maturation, thither are important risks in the evolution, regulative blessing and commercialisation of new products. There are no guarantees that futurity clinical studies discussed in this wardrobe freeing volition be accomplished or successful or that any merchandise testament invite regulative commendation for any denotation or establish to be commercially successful. VIVUS does not contract an duty to update or revisal any advanced instruction. Investors should study the endangerment factors set onward in VIVUS’ Form 10-K for the year terminated December 31, 2008 and periodical reports filed with the Securities and Exchange Commission.
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VIVUS Announces FDA Acceptance Of Qnexa(R) New Drug Application For Treatment Of Obesity
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