- Year-Long Phase 2 Diabetes Study Results Presented at ADA Annual Meeting -
NEW ORLEANS, June 8 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS), a biopharmaceutical company developing innovative, next-generation therapies to address unmet needs in obesity, diabetes and sexual health, today announced that data from a year-long phase 2 trial (DM-230) evaluating Qnexa(TM) in patients with type 2 diabetes are being highlighted in an oral podium presentation at the American Diabetes Association (ADA) 69th Scientific Sessions (abstract 361-OR). The study demonstrated that Qnexa, an investigational new drug, significantly reduced patients' hemoglobin A1c (HbA1c) -- a key indicator of blood sugar control -- and helped patients achieve and maintain significant weight loss. The study also showed that Qnexa had a positive impact on other risk factors associated with diseases prevalent in people living with diabetes.
"While it is widely known that type 2 diabetes can be treated through weight loss, the currently approved weight loss therapies have limitations. The optimal diabetes therapy will not only enable patients to control their blood sugar by lowering glucose levels to the desired range, but will also help patients achieve meaningful weight loss," said W. Timothy Garvey, MD, Professor of Medicine and Chair of the Department of Nutrition Sciences at the
The 56-week randomized, double-blind, placebo-controlled, efficacy and safety study showed:
Overall, the study had a greater than 90 percent completion rate. All results were evaluated based on an intent-to-treat population using the last observation carried forward, known as ITT-LOCF, the method of analysis required by the U.S. Food and Drug Administration.
"Type 2 diabetes is a challenging disease to manage for clinicians and patients alike, especially given the high incidence of co-morbid conditions associated with the disease," said Leland Wilson, president and chief executive officer of VIVUS. "The study results we have seen thus far across the clinical development program for Qnexa reinforce Qnexa's potential in the treatment of type 2 diabetes, and, importantly, in treating co-morbidities including high blood pressure. During last year's ADA meeting, we showed that type 2 diabetics were able to lower their blood sugar and lose weight after six months of treatment with Qnexa. The DM-230 study confirms our original findings and shows continued improvement in blood sugar and sustained weight loss for one year in this difficult-to-treat population."
"Qnexa has shown very promising data to date as a potential therapy to treat obesity in type 2 diabetic patients. This is exciting as it addresses one of the main etiologies of type 2 diabetes -- the weight. This study in a real-world population of type 2 diabetics, applied on a background of rigorous standard of care treatment, shows the true potential of Qnexa in this population," stated Barbara Troupin, M.D., MBA, Clinical Leader for Qnexa Diabetes.
About the DM-230 Study
The DM-230 study was a 56-week, randomized, double-blind, placebo-controlled, efficacy and safety study assessing the impact of Qnexa on glycemic management in 130 obese (90 females, 40 males with an average age of 50 years) type 2 diabetics at 10 study sites. A majority of the patients had been diagnosed with diabetes for more the five years and were taking two or more oral diabetes medications. Subjects in the study were actively managed according to American Diabetes Association (ADA) standards of care with respect to diabetes medications and lifestyle. Patients receiving placebo required significant increases in the number and doses of concurrent anti-diabetic medications to comply with study required glycemic thresholds. Thus, the observed reduction in HbA1c in the placebo treated group was the result of more aggressive medication intervention, while concurrent anti-diabetic medications were reduced in patients treated with Qnexa to meet the same glycemic thresholds. The results of the DM-230 study had previously been released but the ADA podium presentation represents the first time the trial results have been shared with the scientific and medical community.
Qnexa was well-tolerated, with no drug-related serious adverse events. The most common drug-related adverse events reported over the 56 weeks for the treatment and placebo groups, respectively, were tingling, nausea, dry mouth, dizziness, insomnia and constipation. Patients were monitored for depression and suicidality using the PHQ-9 questionnaire, the FDA's preferred mental health assessment tool. Patients treated with Qnexa demonstrated greater improvements in PHQ-9 scores from baseline to the end of the study than the placebo group, providing further assurance that Qnexa treatment does not produce significant adverse mood changes or suicidality.
Despite a mean baseline HbA1c level of 8.7 percent, 53 percent of the subjects treated with Qnexa were able to achieve the ADA recommended goal of 7.0 percent or lower, versus 40 percent of the subjects in the placebo arm (p<0.05). The incidence of treatment-related hypoglycemia was similar in the treatment and placebo arms (2.7% and 1.8%, respectively). There were no cases of severe hypoglycemia.
Diabetes, a chronic medical condition, affects more than 23 million people in the United States and nearly 250 million people worldwide. An estimated 17.9 million have been diagnosed with the disease, however, nearly one quarter are unaware that they have diabetes. New cases of diabetes doubled over the last ten years due to obesity and lifestyle and it is now calculated that the lifetime risk of diabetes in this century is approximately 35 percent.
Common measures of blood sugar include the percent of glycosylated hemoglobin (HbA1c) present in the blood, which gives an assessment of glucose control over the life of a red blood cell (90-120 days), and fasting plasma glucose (FPG), which is a measure of blood sugar at a specific point in time. Diabetes is diagnosed when FPG exceeds 125 mg/dL on two occasions. A newer measure of glucose control is the GlycoMark(TM) test, a blood test which gives a measure of the post-meal glucose spikes over a one to two week period. Since both fasting and post-prandial glucose contribute to what is measured by HbA1c, the addition of GlycoMark provides additional valuable measures of glycemic control. According to the Centers for Disease Control (CDC) and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.
About Postprandial Glucose (PPG) and GlycoMark(TM)
In addition to measurements of hemoglobin A1c and fasting plasma glucose, postprandial glucose levels are used to assess glycemic control. Postprandial (post-meal) glucose refers to blood sugar levels after patients have eaten. As HbA1c levels are reduced to normal levels, assessment of postprandial glucose levels allows for a more precise measure of 24-hour glycemic control. Postprandial glucose is measured indirectly through levels of 1,5-anhydroglucitol (1,5-AG) found in the blood. 1,5-AG levels rise when blood glucose levels are better controlled. GlycoMark(TM) is an FDA approved blood test to measure postprandial glucose via 1,5-AG levels. Increases in 1,5-AG levels represent better glycemic control for patients with type 2 diabetes.
Qnexa (Q-NEX-uh) is a proprietary, low dose, controlled release formulation of phentermine and topiramate that simultaneously addresses both appetite and satiety -- the two main mechanisms that impact eating behavior -- in one daily capsule. Qnexa, an investigational drug, is an obesity therapy being developed to address type 2 diabetes as well as obesity. In phase 2 and phase 3 clinical trials to date, Qnexa has demonstrated significant weight loss, glycemic control, and improvement in cardiovascular risk factors.
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(TM), is expected to complete phase 3 clinical trials for the treatment of obesity in 2009. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes. In the area of sexual health, VIVUS is in phase 3 development with avanafil, a potentially best-in-class PDE5 inhibitor, and in phase 2 development of Luramist(TM) for the treatment of hypoactive sexual desire disorder (HSDD) in women. MUSE(R) (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.
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. Jennifer Torres (312) 624-9802
|SOURCE VIVUS, Inc.|
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