Navigation Links
Upsher-Smith To Present Findings From Global Phase 3 Trial Investigating USL255 (Extended-Release Topiramate) For Adjunctive Treatment Of Epilepsy In Patients With Refractory Partial-Onset Seizures At 2013 American Epilepsy Society Meeting
Date:11/5/2013

MAPLE GROVE, Minn., Nov. 5, 2013 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. (Upsher-Smith), today announced that seven abstracts highlighting results from its Phase 3 (PREVAIL) clinical trial for USL255 (extended-release topiramate) have been accepted for presentation at the American Epilepsy Society's (AES) 67th Annual Meeting in Washington, DC, December 6-10, 2013.

(Logo: http://photos.prnewswire.com/prnh/20130520/NY17281LOGO)

USL255 is a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.  It is being developed by Upsher-Smith for the management of epilepsy.  Upsher-Smith's New Drug Application for USL255 has been accepted for review by the U.S. Food and Drug Administration (FDA).

PREVAIL, a global Phase 3 study, enrolled more than 200 patients at 66 centers to evaluate the safety and efficacy of USL255.  USL255 demonstrated a positive treatment effect as adjunctive therapy in patients with refractory partial-onset seizures (POS) compared with placebo and had a statistically significant reduction from baseline in weekly POS frequency during the titration plus maintenance phase compared to placebo (p<0.001). 

"Upsher-Smith is committed to researching and developing potential treatment options for patients living with challenging central nervous system diseases like seizure disorders," said William Pullman, MB BS, BMedSc, PhD, FRACP, Chief Scientific Officer, Upsher-Smith.  "We look forward to sharing the data from our global Phase 3 clinical trial, the first of its kind conducted on an extended-release formulation of topiramate, with the epilepsy community at this year's AES meeting."

About Upsher-Smith's Phase 3 (PREVAIL) Clinical Trial
The PREVAIL trial was a randomized, multicenter, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of USL255 as adjunctive therapy in patients with refractory POS. 

PREVAIL was conducted under a Special Protocol Assessment (SPA) agreement with the FDA.  More information about the trial is available at www.clinicaltrials.gov (NCT01142193).

An open-label extension study to evaluate the safety of USL255 as adjunctive therapy in patients with refractory POS who had participated in PREVAIL is ongoing.  The open-label extension study can be found by searching NCT01191086 on www.clinicaltrials.gov.

Upsher-Smith's Epilepsy Pipeline
Upsher-Smith's clinical development pipeline includes three investigational drugs that are being studied for the management of seizure disorders.  USL255 is an investigational once-daily, extended-release topiramate for the management of epilepsy.  The pipeline also includes USL261, an investigational intranasal midazolam for the rescue treatment of seizures in patients who require control of intermittent bouts of increased seizure activity, often called seizure clusters, which is the subject of an ongoing international Phase 3 clinical trial (ARTEMIS1) with an open-label safety extension study.  In addition, USL260 (tonabersat) is in early clinical development as a potential first-in-class neuronal gap junction modulator.

About Upsher-Smith
Upsher-Smith, founded in 1919, is an independent and privately-owned specialty pharmaceutical company headquartered in Maple Grove, Minnesota that focuses on product growth and innovation for branded and generic pharmaceuticals.  Upsher-Smith has a particular focus on developing therapies to assist people suffering from central nervous system diseases and also markets products relating to cardiology, dermatology, and women's health.  For more information, visit www.upsher-smith.com.


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

Related medicine technology :

1. Upsher-Smith Announces Development Agreement With Lundbeck
2. Upsher-Smith Announces Commercial Availability Of Morphine Sulfate ER Capsules
3. Upsher-Smith Teams Up With Epilepsy Foundation Of Minnesota For 2013 Stroll For Epilepsy
4. Upsher-Smith Announces Patient Enrollment In Open-label Safety Study Of USL261 (Intranasal Midazolam) For Rescue Treatment Of Seizure Clusters In Epilepsy
5. Upsher-Smith Is Honored With Prestigious Industry Award For Leadership And Innovation
6. Upsher-Smith Successfully Completes Phase III Study Of USL255 (Extended-Release Topiramate) For Adjunctive Treatment Of Epilepsy In Patients With Refractory Partial-Onset Seizures
7. Upsher-Smith Introduces Newly Redesigned Corporate Website
8. Upsher-Smith Presents Data Supporting Favorable Tolerability And Consistent Pharmacokinetic Profile Of Once-Daily USL255 (Extended-Release Topiramate)
9. Emerging Data From Upsher-Smiths CNS Portfolio Highlighted At 2013 American Academy Of Neurology Meeting
10. Doug Zitnak of Upsher-Smith Laboratories Named Small Brand Manufacturer Representative of the Year By Cardinal Health
11. Tina Fehr, Senior Product Manager For AmLactin, Upsher-Smith Laboratories Named PM360 Trailblazer Winner For Womens Health Brand Manager
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... -- Dublin ... the " Global Markets for Spectroscopy Equipment" ... This report focuses on the global market ... its applications in various applications. The report deals with ... main industries: pharmaceutical and biotechnology, food and beverage, and ...
(Date:6/24/2016)... SAN CLEMENTE, Calif. , June 24, 2016  American ... function testing company, is now able to perform sophisticated lung assessments ... ndd Medical Technologies , Inc. Patients are no ...  Thanks to ndd,s EasyOne PRO ® , ARL patients like Jeanne ... needed testing done in the comfort of her own home. ...
(Date:6/24/2016)... NAMUR , Belgium , ...  (NYSE MKT: VNRX), today announced the appointment of ... Board of Directors as a Non-Executive Director, effective ... the Company,s Audit, Compensation and Nominations and Governance ... Board, Dr. Futcher will provide independent expertise and ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... First Choice Emergency Room , the ... Ogunleye, as the Medical Director of its new Mesquite-Samuell Farm facility. , “We ... new Mesquite location,” said Dr. James M. Muzzarelli, Executive Medical Director of First Choice ...
(Date:6/25/2016)... ... ... Friday, June 10, Van Mitchell, Secretary of the Maryland Department of Health and Mental ... exemplary accomplishments in worksite health promotion. , The Wellness at Work Awards took place ... BWI Marriott in Linthicum Heights. iHire was one of 42 businesses to receive an ...
(Date:6/24/2016)... ... ... Those who have experienced traumatic events may suffer from a complex set ... drug or alcohol abuse, as a coping mechanism. To avoid this pain and suffering, ... traumatic event. , Trauma sufferers tend to feel a range of emotions, from depression, ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... and Scientific Sessions in Dallas that it will receive two significant new grants ... grants came as PHA marked its 25th anniversary by recognizing patients, medical professionals ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is ... Road To Recovery® program to drive cancer patients to and from their cancer treatments. ... the highest quality of life and ongoing independence. Getting to and from medical ...
Breaking Medicine News(10 mins):