Additional Data from the Qnexa Phase 3 Studies Presented at The Obesity Society 27th Annual Scientif...(discontinuation rates for disturbance in...),Health

Date:10/29/2009

discontinuation rates for disturbance in attention that were at least three times greater than what was observed in our studies. These results were consistent with the expected profile and previous experience of Qnexa in our studies," stated Leland Wilson, president and chief executive officer of VIVUS. "We believe this additional data further substantiates the safety profile of Qnexa. Taken in the context of the statistically significant weight loss and improvement on co-morbidities, Qnexa has a positive benefit/risk profile. Completion rates for patients on Qnexa were significantly better as compared to placebo in the phase 3 trials. We believe the overall efficacy and safety profile of Qnexa supports approvability."

The company anticipates filing the NDA for Qnexa by the end of 2009.

Previously reported highlights from the EQUIP and CONQUER studies were included in the presentation:

• Average weight loss of 14.7% (37 lbs) was achieved by patients treated with Qnexa for 56 weeks in the EQUIP study;
• Significant improvements in cardiovascular, metabolic and inflammatory risk factors among patients treated with Qnexa;
• FDA efficacy benchmarks for weight loss agents were exceeded at all three doses of Qnexa tested in the clinical program; and
• Completion rates up to 69% were significantly higher than placebo at all three doses of Qnexa, indicating favorable tolerability.
• Across both 56-week studies, the most commonly reported side effects were dry mouth, tingling, constipation, altered taste and insomnia.
• There were no serious adverse events reported for cognitive disorders.
  

EQUIP (OB-302) Study Overview

The EQUIP study included 1,267 morbidly obese patients (1,050 females and 217 males) across 93 centers in the United States. The average baseline BMI of the study population was 42.1 kg/m(2) and baseline weight was 256 pounds. Patients had
'/>"/>

SOURCE VIVUS, Inc. Copyright©2009 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5 6 7 8
Related medicine technology :

1. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
2. Par Pharmaceutical Begins Shipment of Additional Dosage Strength of Generic TOPROL-XL(R)
3. First Osteoporosis Study in Hip Fracture Patients Finds Once-Yearly Reclast(R) Prevents Additional Fractures and Improves Survival
4. PTC Therapeutics Announces Additional Results from Phase 2 Study of PTC124 in Duchenne Muscular Dystrophy
5. Bayer Issues Additional Guidance to Physicians on Trasylol(R)
6. Coley Pharmaceutical Group and Pfizer Nominate Additional Anti-Cancer Compound for Clinical Development
7. Progen Presents Additional Analysis of Data from PI-88 Phase 2 Liver Cancer Study at American Association for the Study of Liver Diseases
8. Pharmacopeia Announces Additional Positive Findings from Phase 1 Multiple Ascending Dose Study of PS433540 (DARA)
9. Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 Study Data
10. Indevus Reports Additional Positive Phase III Trial Data for NEBIDO(R)
11. Paul Capital Healthcare Purchases Additional Royalty Interest in GlaxoSmithKlines Rotarix(R)