MOUNTAIN VIEW, Calif., Sept. 21, 2012 (GLOBE NEWSWIRE) — VIVUS, Inc. (VVUS) currently announced that formed on rough feedback from a European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), a association expects an opinion recommending opposite capitulation of a Marketing Authorization Application (MAA) for Qsiva(TM) (phentermine/topiramate ER) for a diagnosis of obesity. The grave preference from a CHMP is approaching following their Oct 2012 meeting. If a disastrous recommendation is released in October, and depending on a inlet of a objections, a association will possibly resubmit a MAA during a after date or interest this preference and ask a review by a CHMP.
“We wait a central preference and a grave news that should yield us specifics on any additional mandate heading to a capitulation of Qsiva in Europe,” conspicuous Peter Tam, boss of VIVUS. “We will work closely with a CHMP to residence a Committee’s concerns. VIVUS is committed to creation this critical remedy accessible to portly patients in Europe.”
About 50% of adult Europeans are portly or overweight and there are singular diagnosis options in Europe to residence this high unmet medical need. Qsiva was authorized by a FDA in Jul 2012 and was recently launched in a United States underneath a trade name Qsymia(TM). Qsiva was complicated in over 3,500 patients over 56 weeks substantiating it as a protected and effective diagnosis for obesity.
Qsymia(TM) (pronounced Kyoo sim ee’ uh) is indicated as an accessory to a reduced-calorie diet and increasing earthy activity for ongoing weight supervision in adults with an initial physique mass index (BMI) of 30 kg/m2 or larger (obese) or 27 kg/m2 or larger (overweight) in a participation of during slightest one weight-related medical condition such as high blood pressure, form 2 diabetes, or high cholesterol.
Important Safety Information
Qsymia (phentermine and topiramate extended-release) capsules CIV contingency not be used by women who are pregnant; by patients with eye problems (glaucoma); by patients who have been told they have an overactive thyroid; by patients holding a form of anti-depressant called MAOI; or by patients who are allergic to phentermine, topiramate, or any of a mixture in Qsymia.
Qsymia can mistreat your unborn baby. If we take Qsymia while we are pregnant, your baby has a aloft risk for birth defects called split mouth and split palate. You should have a disastrous pregnancy exam before holding Qsymia and each month while holding Qsymia. Use effective birth control (contraception) consistently while holding Qsymia. If we turn profound while holding Qsymia, we should stop holding Qsymia immediately and hit your medical provider right away.
Qsymia can also boost your heart rate, might impact your prophesy and means an increasing vigour in your eyes, and might means disturbances in concentration, attention, memory or speech. Topiramate, a member of Qsymia, might means we to have suicidal thoughts or actions, and might means depression. You should call your medical provider if any of these symptoms occur.
The many common side effects seen in Qsymia clinical studies were rawness in a hands and feet, dizziness, change in taste, difficulty sleeping, constipation, and dry mouth.
VIVUS(R) is a biopharmaceutical association commercializing and building innovative, next-generation therapies to residence unmet needs in obesity, nap apnea, diabetes and passionate health for U.S., Europe and other universe markets. Qsymia (phentermine and topiramate extended-release) capsules CIV for a diagnosis of plumpness is authorized in a U.S. Qsymia is also in proviso 2 clinical growth for a diagnosis of form 2 diabetes and opposed nap apnea. For some-more information about a company, greatfully revisit www.vivus.com.
Certain statements in this press recover are forward-looking within a definition of a Private Securities Litigation Reform Act of 1995. These statements might be identified by a use of forward-looking difference such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “opportunity” and “should,” among others. There are a series of factors that could means tangible events to differ materially from those indicated by such forward-looking statements. These factors include, though are not singular to, a miss of blurb knowledge with Qsymia in a U.S.; a timing of arising and execution of a clinical studies compulsory as partial of a capitulation of Qsymia by a United States Food and Drug Administration, or FDA; a response from a FDA to a information that VIVUS will contention relating to post-approval clinical studies; a impact of a indicated uses and contraindications contained in a Qsymia tag and a REMS requirements; a impact of placement of Qsymia by a approved pharmacy network; that we might be compulsory to yield serve research of formerly submitted clinical hearing data; a response to questions and requests for additional information including additional pre-clinical or clinical studies from a European Medicines Agency, or EMA, and a Committee for Medicinal Products for Human Use, or CHMP, for a Marketing Authorization Application, or MAA, for Qsymia; a story of waste and non-static quarterly results; estimable competition; risks associated to a disaster to strengthen a egghead skill and lawsuit in that we might turn involved; uncertainties of supervision or third celebration payer reimbursement; a faith on solitary source suppliers; a singular sales and selling and production experience; a faith on third parties and a collaborative partners; a disaster to continue to rise innovative investigational drug possibilities and drugs; risks associated to a disaster to obtain FDA or unfamiliar management clearances or approvals and noncompliance with FDA or unfamiliar management regulations; a ability to denote by clinical contrast a reserve and efficacy of a investigational drug candidates; a timing of arising and execution of clinical trials and submissions to unfamiliar authorities; a sensitivity and liquidity of a financial markets; a liquidity and collateral resources; and a approaching destiny revenues, operations and expenditures. As with any curative in development, there are poignant risks in a development, a regulatory approval, and commercialization of new products. There are no guarantees that a response to a CHMP’s 180-day list of superb issues and successive meetings and communications will be sufficient to infer a CHMP’s reserve concerns per Qsymia, that a unfamiliar authorities will not need us to control any additional impending studies or retrospective observational studies, or that any product will accept unfamiliar regulatory capitulation for any denote or infer to be commercially successful. VIVUS does not commence an requirement to refurbish or correct any forward-looking statements. Investors should review a risk factors set onward in VIVUS’ Form 10-K for a year finale Dec 31, 2011, and periodic reports filed with a Securities and Exchange Commission.