Navigation Links
Upsher-Smith Presents New Data On The PK Equivalence Of USL255 (Extended-Release Topiramate) When Sprinkled On Food Or Swallowed Intact

MAPLE GROVE, Minn., Dec. 10, 2013 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. (Upsher-Smith), today announced the presentation of new Phase 1 data showing that USL255 (extended-release topiramate) may provide a beneficial treatment option for individuals with difficulty swallowing whole capsules or tablets.  Additionally, simulations of data from another Phase 1 study demonstrated a return to steady-state topiramate levels within one 24-hour dosing interval, suggesting, for USL255 doses delayed up to 18 hours, the risk of dropping to sub-therapeutic concentrations is minimized.  The data were presented for the first time at the American Epilepsy Society's (AES) 67th Annual Meeting in Washington, DC, December 6-10, 2013. 


Upsher-Smith presented two abstracts with Phase 1 data on USL255, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic (PK) profile.  It is being developed by Upsher-Smith for the treatment of seizure disorders. Upsher-Smith's New Drug Application for USL255 has been accepted for review by the U.S. Food and Drug Administration (FDA). When approved, USL255 may offer dosing flexibility because it can be swallowed whole or the capsule contents of all strengths may be sprinkled onto soft food.

Phase 1 data presented at AES came from a single-dose study (N=36) that evaluated the PK profile of 200 mg of USL255 administered to healthy volunteers. Subjects were randomized to receive both an intact USL255 200 mg capsule taken under fasting conditions and three weeks later a 200 mg capsule of USL255 opened and sprinkled onto one tablespoonful of applesauce after an overnight fast. Researchers found that USL255 when sprinkled on soft food or given intact demonstrated PK equivalence for both AUC and Cmax. The findings indicated that USL255 may provide a beneficial option for individuals with difficulty swallowing whole capsules or tablets.

"The positive results of the Phase 1 study demonstrate that USL255 may help address a common issue facing many patients with seizure disorders: challenges swallowing capsules or tablets," said Barry Gidal, Pharm.D., R.Ph., Division Chair, School of Pharmacy, University of Wisconsin. "This specifically designed formulation with the flexibility of once-daily dosing and the option of sprinkle administration may provide added benefits to patients living with the challenge of seizures."

The second presentation evaluated the pharmacokinetic effects of delayed administration of USL255.  Simulations were conducted to assess the effects of taking USL255 6, 12, 18 and 24 hours later than scheduled.  The data demonstrated a return to near steady-state topiramate plasma concentration within one 24-hour dosing interval after the delayed dose was administered. Administration of USL255 up to 18 hours after a missed dose will minimize the duration of decreased topiramate concentrations without significant risk of increased maximal plasma concentrations.

At the AES conference, Upsher-Smith also presented seven abstracts on its recently completed global Phase 3 study, PREVAIL, which enrolled more than 200 patients at 66 centers to evaluate the safety and efficacy of USL255.

Abstracts of the poster presentations can be found online at  To schedule an interview with an investigator, please contact Jessica Orr at  

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 (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

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

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

Related medicine technology :

1. Upsher-Smith Debuts Positive Results From Global Phase 3 Study Evaluating USL255 (extended-release topiramate) In Epilepsy Patients With Refractory Partial-Onset Seizures
2. Auxilium Pharmaceuticals, Inc. Announces Court Grants Upsher-Smith Laboratories Motion For Summary Judgment
3. Upsher-Smith To Present New Research On USL255 (Extended-Release Topiramate) At 2013 American Epilepsy Society Annual Meeting
4. 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
5. Upsher-Smith Announces Development Agreement With Lundbeck
6. Upsher-Smith Announces Commercial Availability Of Morphine Sulfate ER Capsules
7. Upsher-Smith Teams Up With Epilepsy Foundation Of Minnesota For 2013 Stroll For Epilepsy
8. Upsher-Smith Announces Patient Enrollment In Open-label Safety Study Of USL261 (Intranasal Midazolam) For Rescue Treatment Of Seizure Clusters In Epilepsy
9. Upsher-Smith Is Honored With Prestigious Industry Award For Leadership And Innovation
10. Upsher-Smith Successfully Completes Phase III Study Of USL255 (Extended-Release Topiramate) For Adjunctive Treatment Of Epilepsy In Patients With Refractory Partial-Onset Seizures
11. Upsher-Smith Introduces Newly Redesigned Corporate Website
Post Your Comments:
(Date:12/1/2015)... India , December 1, 2015 ... and segments the concerned market with analysis and forecast ... orthobiologics report defines and segments the concerned market ... According to the Market Research Report "North American Orthobiologics ... Growth Factors & Spinal Stimulation, Stem Cell Therapy, Viscosupplementation), ...
(Date:12/1/2015)... and UPPSALA, Sweden , December 1, 2015 ... by the International Breast Cancer Study Group (IBCSG, ... Brussels ) to be part of a state ... promising new cancer drug.  --> ... advanced breast cancer being treated with anti-hormonal therapy in combination ...
(Date:12/1/2015)... , December 1, 2015 ... the addition of the  "2016 Shigella ... Innovative Technologies, Competitive Strategies, Emerging Opportunities--US, ... Japan"  report to their offering. ... the addition of the  "2016 Shigella ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... December 01, 2015 , ... SAN FRANCISCO, Calif. ... that the organization has awarded Education and Developmental Therapies (EDT), an Applied Behavior ... award celebrates exceptional special needs providers that excel in synthesizing the areas of ...
(Date:12/1/2015)... ... 01, 2015 , ... Lutronic, a leading innovator of aesthetic and medical laser ... devices for sale in the United States. Clarity is a Superior Dual Wavelength ... lasers, into a single platform that is easy to own and operate. , ...
(Date:12/1/2015)... (PRWEB) , ... December 01, 2015 , ... XTC ... selected 10 semi-finalists to head to Las Vegas for CES 2016, the world’s largest ... CEO of Consumer Technology Association Gary Shapiro, Founding Partner of Pacific Investments Veronica Serra, ...
(Date:12/1/2015)... ... ... Nurotron Biotechnology Co., Ltd., maker of cochlear implant systems, has won a ... will be from the China Disabled Persons’ Federation, a central government association, for nearly ... children and adults suffering from severe and profound hearing loss . The company ...
(Date:12/1/2015)... , ... December 01, 2015 , ... ... Center Enterprise Authorized Technology Provider (ATP) status from Cisco. This designation recognizes Tympani ... support Cisco Unified Contact Center solutions targeted to the high-end enterprise contact center ...
Breaking Medicine News(10 mins):