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After 28 weeks of blood sugar levels, as measured by hemoglobin A1c (HbA1c), were lower in the patient treatedwith Qnexa, while the patients in the placebo group had a significant increase in their HbA1c levelzs (p<0.0001). The placebo-adjusted reductions in HbA1c for patients taking Qnex awere 0.11 percent and 0.10 percent for the full-dose and mid-dosd groups (p<0.0001). If HbA1c trajectories during this study were theaverage placebo-treated patient would develop diabetes, per guidelines established by the Americann Diabetes Association (ADA), in approximatelyg eight years. Patients treated with Qnexw had weight lossof 9.2% and 8.
5% on the full-dosr and mid-dose of Qnexa as compared to weight loss of 1.7% in the placebok group (p<0.001). These findings (abstract 119-OR) are being presented by , MD, Clinical Professotr of Medicineat Weill-Cornell University and Director of New York Presbyteriaj Hospital's Comprehensive Weight Control Program, and a lead investigatoe in the study, at the 69th Scientific Sessionse of the ADA. The podium presentatio n will take place during the Novel Diabetes Treatmentx in Development in Humans Sessionfrom 4:00-6:00 locaol time. Dr. Aronne stated, "Obesity is the leadinvg cause of type2 diabetes.
Studiezs have shown that type 2 diabetes can be treated effectivelyg in most patients with significant weight People with weight problems have a disease that can be obesity is more about biology and nota person'sa lack of will power, and we are in desperats need of more effective tools to help our patientxs combat this disease and the othedr serious medical conditions that arise as a resulg of weight gain. Theser study results suggest that Qnexqa is a promising pharmaceutical therapy to assistt patients in achieving weight loss and to halt the progressiojn towards type2 diabetes.
Whild the study was designed as an obesity the positive impact on glycemic endpointz suggests potential health benefits inthe non-diabetic obeser population." "Data from DM-230 showed that treatment with Qnexw will lower HbA1c in diabetic patients, but we now know that for patiente that have not been diagnosed with diabetes, Qnexsa treatment can prevent increases in HbA1c levels. Obesity is the commob cause of type 2 diabetes and other metabolicf andcardiovascular diseases. In this study, treatment with Qnexa arrestedf progression todiabetes completely.
These data highlight the importany but often underappreciated potential of treatingt the major cause of diabetes before the diseasebecomese apparent," said , president and chiedf executive officer of "We expect the CONQUER study, a large ongoin phase 3 study that includes diabetid and pre-diabetic subjects, will further demonstrate the efficacyy of Qnexa for weight loss and effectivre management of glycemic control in diabetic and non-diabetic patients.
" "The clinical program has been carefull designed to test the safety and efficac y of Qnexa in a wide rangde of healthy and co-morbid obese With the high hurdles of benefit/riski set by regulatory and reimbursement authorities, it's not enoug h for a drug to demonstrate weight loss; new obesitgy drugs should have the potential for impacting an importany down-stream consequence of obesity, diabetes. We are excited to see the resultds of the first phase 3 trial supportinvthis goal," said , Ph.D., vice president clinical development at The EQUATE study included 756 obese patients (599 females and 157 across 32 centers in the United States.
The averagwe baseline BMI of the study populationwas 36.3 kg/m2w and baseline weight was 101.3 kg. The study was a double-blind, placebo-controlled, prospective trial with subjectxs randomized toreceive once-a-dag treatment with mid-dose Qnexa (7.5 mg phentermine/46 mg topiramat e CR), full-dose Qnexa (15 mg phentermine/92 mg topiramate CR), the respectivew phentermine and controlled-release topiramate constituents, or placebo. Patientd had a four-week dose titration period followeed by 24 weeksof treatment. Subjects were asked to follow a hypocaloric diet representinva 500-calorie/day deficit and advisex to implement a simplwe lifestyle modification program.
The study found that nearluy two-thirds (66%) of patients treated with Qnexa lost 5 percent or more of theifr initial body weight atthe drug's full dose, 62 percent for mid-dosse and 15 percent for placebo. The proportiohn of Qnexa patients losing 10 percentg or more of their initial body weighgt was 41 percent for 39 percentfor mid-dose and 7 percent for Nearly one-fifth (19%) and 15 percent of the patientz lost at least 15 percent of their body weighty on the full-dose and mid-dose of Qnexaw as compared to 2 percent for the placebo Results were evaluated using ITT-LOCF, the method of analysis requiredx by the U.S. Food and Drug Administration.
Qnexas was well-tolerated, with no drug-related serious adverse events. The most commoj adverse events reported forthe mid-dose and placebo group were dry mouth, altered taste and constipation. The completioj rate for the studyu overall was70 percent. More than 300 milliomn people worldwide and approximatelty 30 percent of Americanadults (more than 60 millionb people) are obese, a chronic condition definesd by having excess body fat. As the seconxd leading cause ofpreventable death, obesity directly contributes to numerous life-threatening conditionsw including diabetes, cardiovascular disease, hypertension and stroke.
Experts agree that even a modesyt weight loss of five percentof weight, maintained over time, can bringv significant health benefits by lowering bloodr pressure and reducing the risk of diabete s and heart disease. Pre-diabetes is a conditionn where blood glucose levels are higher than normal but not yet high enoughb for the patient to be diagnosexdwith diabetes. Blood glucose levels are considered to be norma when Fasting PlasmaGlucose (FPG) is below 100 mg/dL. There are 57 million people in the United Statee and 314 million worldwidew whohave pre-diabetes.
Recent researchb has shown that long-term damagew to the body, especially the heart and circulatory may already be occurringduring pre-diabetes. Baselinre HbA1c levels were 5.48 percent and 5.42 percentr for the full-dose and mid-dos groups. The ADA guideline s suggest that HbA1c levels shouldbe 7.0 percent or Qnexa (Q-NEX-uh) is a proprietary, low controlled release formulation of phentermine and topiramate that simultaneousluy addresses both appetite and satiety -- the two main mechanisms that impacgt eating behavior -- in one daily Qnexa, an investigational drug, is an obesityg therapy being developed to addresw type 2 diabetes as well as weight loss.
In phasse 2 and phase 3 clinical trials to Qnexa has demonstrated significant weight glycemic control, and improvement in cardiovascula r risk factors. Qnexa is well with no drug-related serious adverse events reported to VIVUS is a biopharmaceutical companydeveloping next-generation therapies to address unmet needs in obesity, diabetes and sexuall health. The company's lead product in clinical development, is expected to complete phase 3 clinical trials for the treatmenr of obesityin 2009. Qnexa is also in phase 2 clinicak development for the treatment of type2 diabetes.
In the area of sexua l health, VIVUS is in phase 3 developmengtwith avanafil, a potentially best-in-class PDE5 inhibitor, and in phasew 2 development of Luramist(TM) for the treatment of hypoactive sexual desire disorder (HSDD) in women. (alprostadil), a first generation therapy for the treatmengof ED, is already on the market and generating revenue for VIVUS. For more information about the company, pleasr visit . Certain statements in this press releas eare forward-looking within the meaning of the Private Securitiee Litigation Reform Act of 1995.
These statemente may be identified by the useof forward-lookinv words such as "anticipate," "believe," "forecast,"" "estimated" and "intend," among others. These forward-lookinbg statements are based on VIVUS' current expectations and actual results coulddiffer materially. There are a number of factors that coul cause actual events to differ materially from those indicated bysuch forward-lookinbg statements.
These factors include, but are not limitedd to, substantial competition; uncertainties of patent protectionand litigation; uncertainties of governmenrt or third party payer reimbursement; reliance on sole source suppliers; limitee sales and marketing efforts and dependence upon thirdf parties; risks related to the development of innovative and risks related to failure to obtain FDA clearancesz or approvals and noncompliance with FDA regulations. As with any pharmaceutica under development, there are significan t risks inthe development, regulatory approval and commercialization of new products.
There are no guarantee s that future clinical studieas discussed in this press released will be completed or successful or that any produc t will receive regulatory approval for any indication or provee to becommercially successful. VIVUS does not undertakw an obligation to update or reviseany forward-lookinfg statement. Investors should read the risk factors set forthbin VIVUS' Form 10-K for the year endedr December 31, 2008 and periodic reports filex with the Securities and Exchange Commission. VIVUS, Inc. Investor Relations: The Trout Groupo Timothy E. Morris Brian Korb Chief FinancialOfficer 646-378-29233 650-934-5200 Media Relations: Pure Communications, Inc.
Jennifert Torres 312-624-9802 SOURCE VIVUS, Inc.
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