Navigation Links
Upsher-Smith Presents Data Supporting Favorable Tolerability And Consistent Pharmacokinetic Profile Of Once-Daily USL255 (Extended-Release Topiramate)
Date:3/20/2013

"list-style-type:disc" type="disc">
  • Single, High Doses of USL255, an Extended-Release Topiramate Formulation, are Well Tolerated and Demonstrate a Dose-Proportional Pharmacokinetic Profile in Healthy Subjects 
    P04.212. Session P04:  Epilepsy:  Antiepileptic Medications:  Special Populations and Pharmacokinetics
  • USL255 (Extended-Release Topiramate) Data

    The objective of the single-dose, Phase I study was to determine the maximum tolerated dose (MTD), safety/tolerability, and pharmacokinetics (PK) of ascending doses of USL255 in healthy volunteers.  The study planned for sixty subjects to be randomized (4:1) to USL255 (600, 800, 1000, 1200, 1400 or 1600 mg) versus placebo.  PK samples were drawn, and tolerability and vital signs assessed, out to 14 days post-dose.  Escalation to the next dose level was done only after USL255 demonstrated suitable tolerability four days post-dose, assessed by a priori tolerability criteria.  Dose proportionality and linearity of topiramate exposure was determined using statistical models.  The study results showed single-ascending doses of USL255 were generally well tolerated from 600 – 1200 mg, with 1200 mg established as the MTD.  AUC and Cmax were dose proportional and linear over the entire 600 – 1400 mg dose range.

    USL255 is an investigational treatment being developed for the management of epilepsy in adults and is also the subject of a global Phase III clinical trial (PREVAIL).  Information about the trial can be found at http://www.clinicaltrials.gov (NCT01142193).

    Upsher-Smith's Epilepsy Pipeline

    Upsher-Smith's clinical development pipeline includes three investigational drugs that are being studied for the management of epilepsy.  USL255 is an i
    '/>"/>

    SOURCE Upsher-Smith Laboratories, Inc.
    Copyright©2012 PR Newswire.
    All rights reserved

    Page: 1 2 3 4

    Related medicine technology :

    1. Upsher-Smith Research Shows Unique Pharmacokinetic Profile of USL255 Extended Release Topiramate
    2. Dave Zitnak Of Upsher-Smith Laboratories Named Branded Representative Of The Year By McKesson Corporation
    3. Upsher-Smith Is Honored with Prestigious Industry Award for Excellence and Innovation
    4. Upsher-Smith Teams Up With Epilepsy Foundation of Minnesota for 2012 Stroll for Epilepsy
    5. Tina Fehr, Senior Product Manager For AmLactin, Upsher-Smith Laboratories Named PM360 Trailblazer Winner For Womens Health Brand Manager
    6. Doug Zitnak of Upsher-Smith Laboratories Named Small Brand Manufacturer Representative of the Year By Cardinal Health
    7. Emerging Data From Upsher-Smiths CNS Portfolio Highlighted At 2013 American Academy Of Neurology Meeting
    8. Report Presents a Framework for Successful New Oncology Product Launches in the Pharmaceutical Sector
    9. Foundation for Managed Care Pharmacy (FMCP) Presents Awards for 2012 National P&T Competition and Best Posters
    10. Sanofi Pasteur Presents Pediatric Data on Investigational Quadrivalent Influenza Vaccine
    11. Grant & Eisenhofer Represents Lead Whistleblower in Historic $1.6 Billion Settlement with Abbott Laboratories Over Off-Label Marketing of Antiepileptic Medication Depakote
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:8/20/2014)... YORK , Aug. 20, 2014 ... is available in its catalogue: The ... http://www.reportlinker.com/p02051938/The-Market-for-Medical-Devices-in-EMEA .html The European, Middle Eastern ... of medical devices. As part of its coverage, ... EMEA concentrates on the EMEA medical device markets ...
    (Date:8/20/2014)... Aug. 20, 2014 ... is available in its catalogue: EMR ... http://www.reportlinker.com/p0833392/EMR-2014-The-Market-for-Electronic-Medical-Records.html Kalorama ... medical records (EMR) for nearly a decade, and ... our findings. Our report has become the industry ...
    (Date:8/19/2014)... NASHVILLE, Tenn. , Aug. 19, 2014 /PRNewswire/ ... to provide its patient experience technology to ... Health. Under the five-year agreement, CarePoint Health will ... of Bayonne Medical Center, Christ Hospital and Hoboken ... platform offers a range of software solutions to ...
    Breaking Medicine Technology:The Market for Medical Devices in EMEA 2The Market for Medical Devices in EMEA 3The Market for Medical Devices in EMEA 4The Market for Medical Devices in EMEA 5EMR 2014: The Market for Electronic Medical Records 2EMR 2014: The Market for Electronic Medical Records 3EMR 2014: The Market for Electronic Medical Records 4EMR 2014: The Market for Electronic Medical Records 5EMR 2014: The Market for Electronic Medical Records 6EMR 2014: The Market for Electronic Medical Records 7EMR 2014: The Market for Electronic Medical Records 8Lincor Announces Agreement With CarePoint Health For State-Of-The-Art Patient Engagement Technology 2
    ... 12, 2012 Arriva Medical, a leading national ... has acquired Direct Diabetic Source, Inc. in a ... included a cash payment of $2.5 million at ... total $2.5 million.  Based in Sunrise, FL, Direct ...
    ... Ill. and SALT LAKE CITY, Jan. 12, 2012   ... supplies and equipment to school nurses, athletic trainers and ... EnableMart, a leading provider of assistive technology to the ... and arranged the transaction. In recent ...
    Cached Medicine Technology:School Health Corporation Acquires EnableMart to Expand Product Offering Into Schools 2School Health Corporation Acquires EnableMart to Expand Product Offering Into Schools 3
    (Date:8/21/2014)... (PRWEB) August 21, 2014 While golfing ... found it hard to stay focused on his game ... mosquitoes. The constant whine, slapping and continual need to ... innovative methods to stay protected from insects while golfing. ... career in the Financial Services/Investment Banking Industry, decided to ...
    (Date:8/21/2014)... 21, 2014 Denver marketing agency ... for the American Lung Association in Colorado’s 2014 ... welcome Webolutions as a sponsor,” said Curt Huber, Chief ... Executive Director, American Lung Association in Colorado, “and we’re ... in this role they’ve defined.” , Webolutions has also ...
    (Date:8/21/2014)... August 21, 2014 HIPAA Secure Now! ... making it possible for EHR vendors to now offer ... requirement for achieving meaningful use. , HIPAA Secure ... to medical practices throughout the U.S. The company assesses ... information (ePHI) from each system and device used by ...
    (Date:8/21/2014)... Consilium Staffing, Your Partner in Locum Tenens, ... in response to the President’s landmark VA hospital reform ... the Department of Veterans Affairs to hire more doctors. ... one hundred fifty medical centers nationwide, and has been ... awaiting treatment, including vets from the Vietnam War, Iraq, ...
    (Date:8/21/2014)... PA (PRWEB) August 21, 2014 The ... Crossing Historic Park in Washington Crossing, Pennsylvania on Thursday, ... the park. “We have been looking for different ways ... said Matt Kiernan, Partner with Pharmica Consulting. “When we ... part of U.S. history, we jumped at the opportunity.” ...
    Breaking Medicine News(10 mins):Health News:Financial VP Fights Pesky Bugs with Launch of Biteback Sports Insect Shield® Golf Apparel 2Health News:Denver Marketing Agency Webolutions Named Inspirational Sponsor for 2014 Run the ‘Rocks 5K 2Health News:Denver Marketing Agency Webolutions Named Inspirational Sponsor for 2014 Run the ‘Rocks 5K 3Health News:HIPAA Secure Now! Ramps up EHR Partner Program, Helps Healthcare Providers Achieve Meaningful Use under Revised CMS Deadlines 2Health News:Consilium Staffing Providing Locum Tenens in Response to VA Hospital Reform Legislation 2Health News:Pharmica Spends the Day Helping to Preserve Washington Crossing Historic Park 2
    ... Women,s Health Study Reveals that Strawberries May Help Reduce ... Having Elevated Inflammation in ... are not only,delicious and nutrient-rich, new research from Harvard ... The new study found,that those who reported eating the ...
    ... Up-Time and Improved Overall ... Laboratory ... (http://www.siemens.com/diagnostics ) announced today,worldwide availability of version 2.0 software ... will be a required upgrade for,all existing customers and included ...
    ... stepping into the national limelight with the establishment ... Research., The new center, funded by a $10 ... Health (NIMH), will support interdisciplinary studies aimed at ... in the brain., The neurotransmitter serotonin is central ...
    ... Inc. (NYSE: MYL ),today announced the appointment ... of Global Technical Operations. Mr. Malik has served ... acquired a controlling stake in Matrix,Laboratories Limited (Matrix), ... As Head of Global Technical Operations, Mr. ...
    ... Inc. (NYSE: MYL ),today announced the appointment of ... East and Africa) following the completion,of Mylan,s acquisition of ... Barret most recently served as Region Director,EMEA, reporting to ... 2004,following his role as Area Director for Southern Europe, ...
    ... disease care, study finds , , TUESDAY, Oct. 2 (HealthDay ... rates of chronic disease in the United States, with ... a new study finds. , It,s an expensive problem, ... and heart disease account for some $100 to $150 ...
    Cached Medicine News:Health News:Strawberry Consumption Associated with C-Reactive Protein Among Women: New Harvard Study 2Health News:Siemens Medical Solutions Diagnostics Announces the Release of the Rapidlab 1200 Series Version 2.0 Software 2Health News:Siemens Medical Solutions Diagnostics Announces the Release of the Rapidlab 1200 Series Version 2.0 Software 3Health News:Vanderbilt nets brain gene research center 2Health News:Vanderbilt nets brain gene research center 3Health News:Mylan Appoints Rajiv Malik as Executive Vice President, Head of Global Technical Operations 2Health News:Mylan Announces Appointment of Didier Barret as President, Europe, Middle East and Africa 2Health News:Obesity Driving Rising U.S. Health Costs 2Health News:Obesity Driving Rising U.S. Health Costs 3
    ... Autolet Impression is the advanced lancing device ... Owen Mumford. Autolet Impression features unique Comfort ... ultimate control and comfort when lancing. Comfort ... targeting the sensation and perception of pain. ...
    ... The Qwik-Let Elite has become ... sold models. This popularity is due ... features found in the design and ... this innovative device is priced for ...
    ... new Finnpipette Focus from Thermo Labsystems was ... performance. Advanced features such as the ... volume adjustment on microvolumes help to define ... channel pipettes. The new interchangeable handle plate ...
    ... Seven digital models cover the range from ... liquid fluently. Volume lock design prevents inadvertent ... the horizontal grip. Whole pipette is autoclavable ... ejector is all polypropylene. Suitable for one-handed ...
    Medicine Products: