Navigation Links
Additional Data from the Qnexa Phase 3 Studies Presented at The Obesity Society 27th Annual Scientific Meeting
Date:10/29/2009

on were pooled by dose across all one-year studies in an effort to provide a more accurate estimation of the incidence of each event. This pooled analysis, presented in September, which is a part of the Integrated Summary of Safety (ISS) in the Qnexa NDA, demonstrates that the discontinuation rates for these various cognitive-related events were low and all occurred at a frequency of less than 1%. Specifically, the discontinuation rates from the ISS due to cognitive events from the year-long Qnexa studies (OB-302, OB-303 and OB-202/DM-230) were:


    MedDRA Preferred Terms             Qnexa    Qnexa    Qnexa    Qnexa All
                            Placebo     Low      Mid      Full     doses
                           (n=1,561)  (n=240)  (n=498) (n=1,580)  (n=2,318)
                            -------    -----    -----   -------    -------
    Disturbance in
     Attention               0.2%       0.0%     0.0%     0.9%       0.6%
    Memory Impairment        0.1%       0.0%     0.0%     0.3%       0.2%
    Amnesia (forgetfulness)  0.1%       0.0%     0.2%     0.4%       0.3%
    Aphasia (word finding
     difficulties)           0.0%       0.0%     0.0%     0.3%       0.2%
    Cognitive Disorder       0.1%       0.0%     0.0%     0.1%       0.1%
    Confusional State        0.1%       0.4%     0.2%     0.1%       0.2%
    Bradyphrenia (slow
     thinking)               0.0%       0.0%     0.0%     0.1%       0.0%
    Disorientation           0.0%       0.0%     0.0%     0.0%       0.0%
    Mental Impairment        0.0%       0.0%     0.0%     0.0%       0.0%

    Events are not additive as some patients have reported more than one
    event leading to study drug discontinuation

Of the events shown in the table above, the most frequent reason for patients discontinuing Qnexa was disturbance in attention. For the 1,580 patients receiving full dose Qnexa, the discontinuation rate for this event was 0.9%. This rate is considerably lower
'/>"/>

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

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)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... 2014  Novation, the leading health care supply chain expertise, ... reseller (VAR) national contracts that expand its portfolio to ... lower costs. These include manufacturer product and service agreements, ... and ongoing IT consulting support. New ...
(Date:1/15/2014)... DUBLIN , January 15, 2014 Shire plc ... waived the Office of Fair Trading (OFT) approval condition to the ... Incorporated (NASDAQ: VPHM).   As a result of the ... Shire expects to complete the tender offer on January 24, 2014 ...
(Date:1/15/2014)...  Manufacturers, suppliers and distributors of innovative medical-related products ... most important business assets, intellectual property (IP). ... Because of the highly-competitive nature of the Medical ... most litigious industry sectors of cases involving IP ...
Breaking Medicine Technology:New Novation Information Technology VAR Contracts Offer Significant Savings to Hospitals 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 3Intellectual Property Insurance for Medical-related Products and Services 2
... Incorporated (NASDAQ: VPHM ) today announced the ... ILNS) to its clinical stage drug candidate, OX1, being ... rare, hereditary, progressive neurodegenerative disease. OX1, ... molecule that has potent anti-oxidant properties that can protect ...
... KIRKLAND, Wash., Sept. 29, 2011 Cardiac Dimensions®, Inc. ... Mark approval for a newly enhanced version of its ... heart failure patients suffering from functional mitral regurgitation (FMR). ... initiate a commercial launch of the enhanced device in ...
Cached Medicine Technology:ViroPharma Licenses Rights From Intellect Neurosciences for Product Candidate for Friedreich's Ataxia 2ViroPharma Licenses Rights From Intellect Neurosciences for Product Candidate for Friedreich's Ataxia 3ViroPharma Licenses Rights From Intellect Neurosciences for Product Candidate for Friedreich's Ataxia 4Cardiac Dimensions® Receives CE Mark Approval for Enhanced CARILLON® Mitral Contour System™ 2Cardiac Dimensions® Receives CE Mark Approval for Enhanced CARILLON® Mitral Contour System™ 3
(Date:7/11/2014)... MIDDLEBURY, CT (PRWEB) July 11, 2014 ... announced today the launch of the Timex Performance Network, ... product information, training plans, athlete testimonials, seasonal news and ... Performance Network will capitalize on the legacy of the ... online destination for runners and endurance athletes nationwide. The ...
(Date:7/11/2014)... 11, 2014 (HealthDay News) -- Polio is history in ... like Afghanistan, Nigeria and Pakistan. Giving vaccinated children an ... immunity and help eradicate the highly infectious disease, a ... highly effective, immunity wanes as early as a year ... infected and contribute to the spread of the disease, ...
(Date:7/11/2014)... AngelWeddingDress is now providing worldwide clients with ... ”. When it comes to buying summer wedding dresses ... the unlimited stock of beautiful wedding gowns. Recently, the ... summer wedding gowns. , The company’s current promotion ... pace with the newest fashion trends. The top experts ...
(Date:7/11/2014)... Alliance Labs announced that they will be featured ... Jr, airing later this year 2014, via Discovery Channel. ... Innovations will explore DocuSol® Kids, a mini-enema containing a ... base designed to give adolescents general constipation relief. Viewers ... hyperosmotic laxative by drawing water into the bowel from ...
(Date:7/11/2014)... July 11, 2014 Anterior Cruciate Ligament ... but the type of material used to create a ... the game, say researchers presenting their work today at ... Sports Medicine ( AOSSM ). , “Our ... allografts (tissue harvested from a donor) fail more frequently ...
Breaking Medicine News(10 mins):Health News:Timex Announces Launch of Timex Performance Network 2Health News:Researchers Assess New Way to Boost Polio Immunity 2Health News:AngelWeddingDress Will Continuously Unveil More Summer Wedding Dresses for Loyal Clients 2Health News:Alliance Labs & DocuSol® to be Featured in Upcoming Episode of Innovations 2Health News:ACL Reconstructions May Last Longer With Autografts 2
... cases from two severely disabled children. These cases were mainly ... negligent medical advice. //One such is that of Alexia Harriton, ... that her family doctor had not informed her mother about ... is that of a five-year-old Keeden Waller who was born ...
... The Australian Medical Association announced today that six doctors ... the implementation of new rosters,//which they contend could harm ... doctors are simply expressing displeasure over the new working ... the resignation of the doctors was effective from this ...
... the doctors of the Royal College of Physicians it was ... //It was found that about 73% of the doctors were ... dying where it states that the doctors should be given ... the terminally ill person. But the physicians of the ...
... Office workers are at an increased risk of being affected ... hours on their computer.// DVT is a condition that gives ... the heat or the lung with often fatal consequences. ,This ... e-thrombosis. The condition came to light after it emerged that ...
... take place on June 18 has been advanced to ... the advancement but the centre is against the advancement ... the death of about 1,000 to 2,000 lives every ... children in Muslim-dominated areas are dying. About 5.2 million ...
... from Uttar Pradesh has disproved the claims of health authorities ... been reported in the state. ,This is reported ... (NPSP) issued here this month. ,Some of the ... by the state but also by international agencies like UNICEF, ...
Cached Medicine News:Health News:Fresh Polio Cases Reported In Uttar Pradesh 2
... Advanced diagnostic capabilities combined with ease of ... product in its class. Ideal for office ... complete system for Uroflowmetry, cystometry, leak point ... configurations are available which make the OM-5 ...
... with ease of use make the OM-5 ... Ideal for office or hospital-based urodynamics, the ... cystometry, leak point pressure, or urethral pressure ... make the OM-5 flexible enough to meet ...
... with ease of use make the OM-5 ... Ideal for office or hospital-based urodynamics, the ... cystometry, leak point pressure, or urethral pressure ... make the OM-5 flexible enough to meet ...
... capabilities combined with ease of use make ... its class. Ideal for office or hospital-based ... for Uroflowmetry, cystometry, leak point pressure, or ... available which make the OM-5 flexible enough ...
Medicine Products: