Navigation Links
Upsher-Smith Laboratories Announces Initiation of Phase III Clinical Trial of USL255 (Extended-Release Topiramate) for Adjunctive Treatment of Partial-Onset Epilepsy
Date:6/14/2010

MAPLE GROVE, Minn., June 14 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. today announced the initiation of a global Phase III clinical trial for USL255 (extended-release topiramate), an internally developed program for the management of epilepsy in adults, using the company's proprietary formulation technology.  USL255 is designed to provide convenient once-daily dosing and reduce fluctuations in topiramate blood levels observed with currently available topiramate options.

"The initiation of the Phase III trial for USL255 is a key milestone in Upsher-Smith's vision of becoming a leader in the CNS field," said Alan Rauch, M.D., Chief Medical Officer and Vice President Medical & Regulatory Affairs.  "There is a significant unmet need in the treatment of epilepsy, with as many as 30 percent of patients not adequately controlled using current antiepileptic drugs.  Poor medication compliance may be a contributing factor, and we are excited about the potential for USL255 to offer patients and clinicians a new treatment option with the potential for improved compliance."

The Phase III trial is a randomized, multinational, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of USL255 in patients 18 to 75 years of age with refractory partial-onset seizures with or without secondary generalized seizures.  Further information on this clinical study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01142193?term=upsher&rank=2.

USL255 is the lead investigational drug in Upsher-Smith's expanding CNS development pipeline that includes two other investigational drug programs.  In April 2010, the company obtained exclusive rights in North America for the investigational drug tonabersat, a first-in-class neuronal gap junction modulator. Based on results of preclinical models of seizures, Upsher-Smith will focus on development of tonabersat for the treatment of epilepsy. In July 2008, Upsher-Smith entered into a worldwide licensing agreement with Proximagen Neuroscience Plc for the development and commercialization of the PRX1 program for the symptomatic treatment of Parkinson's disease.

About Epilepsy and Parkinson's Disease

Epilepsy is a neurological condition that produces seizures affecting a variety of mental and physical functions.  Almost three million people in the U.S. have some form of active epilepsy with about 200,000 new cases of epilepsy diagnosed each year.(1)

Parkinson's disease is a chronic, progressive neurodegenerative disease that causes impairment in motor function, as well as many non-motor complications throughout the various stages of the disease.  As many as 1 million people in the U.S. suffer from Parkinson's disease, with 1 in 100 people over the age of 60 affected.(2)

About Upsher-Smith

Upsher-Smith Laboratories, Inc., founded in 1919, is a rapidly growing, privately held pharmaceutical company that develops, manufactures, and markets prescription and over-the-counter products.  Upsher-Smith's product portfolio focuses in the areas of women's health, dermatology, cardiology, and central nervous system diseases.  The company's growing CNS pipeline concentrates on diseases with significant unmet need, including epilepsy and Parkinson's disease.  To expand its CNS pipeline, Upsher-Smith seeks alliances and co-development programs, pursues licensing and acquisitions, and leverages the development of its core competency in formulation development.  For more information, visit www.upsher-smith.com.

1. Epilepsy Foundation. Available at: http://www.epilepsyfoundation.org/.  Accessed on May 19, 2010.

2. The Michael J. Fox Foundation for Parkinson's Research. Available at: http://www.michaeljfox.org/.  Accessed on May 19, 2010.


'/>"/>
SOURCE Upsher-Smith Laboratories, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Upsher-Smith Introduces New Formulation of PreNexa® Prenatal Vitamins
2. Upsher-Smith Announces New Formulation of PreNexa(R) Prenatal Vitamins
3. Upsher-Smith Announces Milestone in Development of CNS Strategy
4. New Data: Cholesterol Management Analysis of Upsher-Smiths Slo-Niacin(R) Tablets in Combination with Lipitor(R)
5. Dr. Chunhao Zhang Joins Asymchem Laboratories
6. Watson Confirms Columbia Laboratories Filing of Definitive Proxy Relating to Watsons Acquisition of U.S. Rights to CRINONE® Progesterone Gel Product Line
7. Perrigo Acquires Rights to Generic Version of HalfLytely® from Novel Laboratories
8. Health Network Laboratories (HNL) Enters Into License Agreement With Hunter Laboratories to Provide HunterHeart Cardiovascular Disease Management Program.
9. Forensic Laboratories Selected for Colorado Companies to Watch Award
10. Kettering Health Network Partners With DIATHERIX Laboratories To Improve Quality, Efficiency of Care
11. Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Eloxatin(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... Alzheimer Diagnostic Tests - Medical Devices Pipeline Assessment, ... report , "Alzheimer Diagnostic Tests - Medical Devices ... Diagnostic Tests currently in pipeline stage. The ... with comparative analysis of the products at various ... involved in the pipeline product development. It also ...
(Date:2/8/2016)... 2016 CBG Technologies, a U.S. company, ... Recycling Systems, specifically designed for precision parts cleaning. ... and existing vapor degreasers, parts washers and ultrasonic ... continuous recycling and recovers 100% of the solvent ... --> Precision parts manufacturers benefit from this ...
(Date:2/8/2016)... 2016 --> ... "Ablation Technologies Market by Product (Radiofrequency, Ultrasound, Irreversible Electroporation, ... Surgery, Ophthalmology, Gynecology) - Global Forecasts to 2020", published ... the forecast period of 2015 to 2020. The market ... CAGR of 10.5% from 2015 to 2020. ...
Breaking Medicine Technology:
(Date:2/8/2016)... ... February 08, 2016 , ... ... newly redesigned website, federallabs.org . The site houses a wealth of federal ... federal technologies through the process called technology transfer (T2). As a network of ...
(Date:2/8/2016)... ... ... has struggled to quit smoking, a man who has struggled with hair loss – Craig ... problems – and he did. Now Nabat, a serial entrepreneur featured as the October 2015 ... the world and better people's lives. His own experience with nicotine addiction led to the ...
(Date:2/8/2016)... Indianapolis, IN (PRWEB) , ... February 08, 2016 ... ... serving the Indianapolis, IN metro area, has selected the latest beneficiary of their ... nonprofit organization dedicated to preventing bullying in area schools. Donations are now being ...
(Date:2/8/2016)... ... 08, 2016 , ... Eating disorders and post-traumatic stress disorder ... and men with eating disorders report a history of trauma, research suggests that ... an eating disorder. , At the 2016 iaedp Symposium, the workshop, “What ...
(Date:2/8/2016)... ... February 08, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating ... Moles are derived from a cluster of melanin when exposed to sunlight. Although most ... create a lifetime of embarrassment. Historically, mole removal has involved a painful, ...
Breaking Medicine News(10 mins):