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Upsher-Smith To Present New Research On USL255 (Extended-Release Topiramate) At 2013 American Epilepsy Society Annual Meeting

November 18, 2013

Multiple Presentations Highlight Findings from Phase 3 Trial Investigating USL255 for Adjunctive Treatment of Epilepsy in Patients with Refractory Partial-Onset Seizures

MAPLE GROVE, Minn., Nov. 18, 2013 /PRNewswire/ — Upsher-Smith Laboratories, Inc. (Upsher-Smith), today announced that it will present new research from its epilepsy clinical development program for USL255 (extended-release topiramate) during the American Epilepsy Society’s (AES) 67(th) Annual Meeting in Washington, DC, December 6-10, 2013.

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Seven presentations will highlight results from the PREVAIL clinical trial, the first of its kind conducted on an extended-release formulation of topiramate. The global Phase 3 study enrolled more than 200 patients and assessed the efficacy and safety of USL255 as an adjunctive treatment of epilepsy in patients with refractory partial-onset seizures (POS). In addition, two presentations will feature Phase 1 findings including the pharmacokinetics of USL255 when sprinkled onto food or swallowed intact and the impact of delayed-dose administration of USL255.

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 seizure disorders. Upsher-Smith’s New Drug Application for USL255 has been accepted for review by the U.S. Food and Drug Administration (FDA).

“This year’s AES meeting marks the first time the findings from our Phase 3 trial will be presented publicly,” said William Pullman, MB BS, BMedSc, PhD, FRACP, Chief Scientific Officer, Upsher-Smith. “We look forward to sharing data from the first global Phase 3 clinical trial of an extended-release formulation of topiramate with the epilepsy community at this year’s Annual Meeting.”

Poster Presentations

PREVAIL Phase 3 Clinical Trial

    --  USL255, a Once-Daily, Extended-Release Topiramate, is Efficacious as an
        Adjunctive Therapy for Refractory Partial-Onset Seizures:  Results from
        the Randomized Phase 3 PREVAIL Clinical Trial   Poster 1.221; Saturday,
        December 7, 2013; 12 p.m. - 6 p.m. EST;   Authors Present 12 p.m. - 2
        p.m.

    --  USL255 is Efficacious Across all Partial-Onset Seizure Types and with a
        Variety of Concomitant Antiepileptic Drugs:  Results from Subgroup
        Analyses of the Phase 3 PREVAIL Clinical Trial   Poster 2.116; Sunday,
        December 8, 2013; 8 a.m. - 5 p.m. EST;  Authors Present 12 p.m. - 2 p.m.

    --  Time to Onset of Efficacy and Sustained Treatment Effects of USL255:
        Results from the Phase 3 PREVAIL Clinical Trial Poster 1.222; Saturday,
        December 7, 2013; 12 p.m. - 6 p.m. EST;   Authors Present 12 p.m. - 2
        p.m.

    --  Safety and Tolerability of USL255 in Subjects with Refractory
        Partial-Onset Seizures:  Results from the Randomized, Phase 3 PREVAIL
        Clinical Trial   Poster 1.219; Saturday, December 7, 2013; 12 p.m. - 6
        p.m. EST;   Authors Present 12 p.m. - 2 p.m.

    --  USL255, a Once-Daily, Extended-Release Topiramate, has Positive Effects
        on Clinical Outcomes and Quality of Life:  Results from the Phase 3
        PREVAIL Clinical Trial   Poster 1.223; Saturday, December 7, 2013; 12
        p.m. - 6 p.m. EST; Authors Present 12 p.m. - 2 p.m.

    --  Long-Term Open-Label Extension (OLE) Study Evaluating the Safety and
        Efficacy of USL255, Once-Daily Extended-Release Topiramate, in Patients
        with Partial-Onset Seizures:  Interim Analysis from PREVAIL OLE  Poster
        2.117; Sunday, December 8, 2013; 8 a.m. - 5 p.m. EST;   Authors Present
        12 p.m. - 2 p.m.

    --  Use of Investigator Training to Improve Seizure Classification in
        PREVAIL - a Phase 3, Global Study Evaluating USL255, Once-Daily
        Extended-Release Topiramate, in Adults with Partial-Onset Seizures
        Poster 3.214; Monday, December 9, 2013; 8 a.m. - 3:30 p.m. EST;
        Authors Present 12 p.m. - 2 p.m.

USL255 Phase 1

    --  Comparison of the Pharmacokinetics of USL255, an Extended-Release
        Topiramate, when Sprinkled onto Food or Swallowed Intact   Poster 1.220;
        Saturday, December 7, 2013; 12 p.m. - 6 p.m. EST;   Authors Present 12
        p.m. - 2 p.m.

    --  Impact of Delayed-Dose Administration of USL255, an Extended-Release
        Topiramate Formulation   Poster 2.157; Sunday, December 8, 2013; 8 a.m.
        - 5 p.m. EST;   Authors Present 12 p.m. - 2 p.m.

Abstracts of the poster presentations can be found online at www.aesnet.org. To schedule an interview with an investigator, please contact Elizabeth Likly at elikly@klcpr.com.

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.


Source: PR Newswire