Eisai Announces Final Results from Phase 3 Open-Label Study of Rufinamide at American Epilepsy Society (AES) Annual Meeting

WOODCLIFF LAKE, N.J., Dec. 5, 2016 /PRNewswire/ -- Eisai Inc. announced today final results of its Phase 3 open-label two-year study of rufinamide, which were presented at the 2016 Annual Meeting of the American Epilepsy Society (AES) held from December 2-6 in Houston, Texas. Analysis of final two-year safety, tolerability and cognitive data showed that patients who received add-on therapy with rufinamide experienced similar safety and tolerability profiles, cognitive development and behavior, compared to those who were treated with antiepileptic drug (AED) therapy of the investigator's choice.

Rufinamide, marketed as BANZEL^®, is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients one year of age and older, and in adults. Please see Important Safety Information for BANZEL below.

LGS is a severe form of epilepsy that affects 1 to 4 percent of all U.S. children with epilepsy. Characterized by multiple seizure types, the disorder is extremely difficult to control, with patients normally having to take several different AEDs. LGS is also accompanied by delayed intellectual development.

"LGS is a rare, complex and difficult to treat condition," said Andrew Satlin, MD, Co-Author and Executive Vice President and Head of Global Clinical Development in the Neurology Business Group, Eisai Inc. "We are pleased to provide these additional data on rufinamide's safety and tolerability, and on cognitive development and behavior. Eisai remains committed to continued research and fulfilling the needs of this underserved population."

About Study 303

In Study 303, 37 patients with inadequately controlled LGS were randomized 2:1 to receive either rufinamide as an add-on to their existing treatment regimen (n=25), or an approved, investigator-chosen AED as an add-on to their existing treatment (n=12). Cognitive development and behavioral effects were assessed via the Child Behavior Checklist (CBCL) Total Problems Score and change from baseline in CBCL Total Problems Score at the end of 2 years (106 weeks).

Some subjects were in the borderline/clinical range in problem area scales, suggesting high cognitive impairment at baseline that persisted throughout the study. Limitations of these analyses include the small sample sizes and greater baseline disease severity of many subjects.

An interim analysis of Study 303 showed that the pharmacokinetic and safety profiles were consistent with those seen in studies conducted in patients ages four and above. 

About BANZEL (rufinamide)

BANZEL (rufinamide) is an anti-epileptic drug indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 1 year and older and adults. BANZEL is a triazole derivative that is structurally unrelated to currently marketed antiepileptic drugs (AEDs). The clinical significance of this structural difference has not been established. It is believed to exert its effect by regulating the activity of sodium channels in the brain which carry excessive electrical charges that may cause seizures.

Important Safety Information for BANZEL (rufinamide)

Contraindication:

• BANZEL is contraindicated in patients with Familial Short QT syndrome.

Warnings:

• AEDs increase the risk of suicidal thoughts or behavior in patients. Patients, their caregivers, and families should be informed of the risk and advised to monitor and report any emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior, or thoughts of self-harm. If these symptoms occur, consider if it may be related to the AED or illness because epilepsy itself can increase these risks.
• Use of BANZEL has been associated with central nervous system–related adverse reactions, such as somnolence or fatigue, coordination abnormalities, dizziness, gait disturbances, and ataxia.

Precautions:

• Formal cardiac ECG studies demonstrated shortening of the QT interval (mean = 20 msec, for doses ≥ 2400 mg twice daily) with BANZEL. Caution should be used when administering BANZEL with other drugs that shorten the QT interval.
• Multi-organ hypersensitivity syndrome has been reported in association with BANZEL therapy. In clinical trials, hypersensitivity reactions occurred in children less than 12 years of age and within 4 weeks of starting BANZEL therapy. In addition, rare cases of Drug Reaction with Eosinophilia and Systemic Symptoms and Stevens-Johnson syndrome have been reported in association with rufinamide therapy post marketing. If any of these reactions are suspected, BANZEL should be discontinued and alternative treatment started. All patients who develop a rash while taking BANZEL must be closely supervised.
• As with all AEDs, BANZEL should be gradually withdrawn to minimize the risk of increased seizure frequency.

Adverse reactions:

In the pooled, double-blind, adjunctive therapy studies in adults and pediatric patients ages 4 and older, the most commonly observed (≥10%) adverse reactions with BANZEL vs placebo, respectively, were headache (25% vs 20%), dizziness (17% vs 10%), fatigue (15% vs 9%), somnolence (13% vs 9%), and nausea (11% vs 7%).

In a multicenter, parallel group, open-label study in pediatric patients (1 year to less than 4 years of age) the most commonly observed (≥10%) adverse reactions and with a higher frequency with BANZEL vs any other AED, respectively, were vomiting (24% vs 9%), somnolence  (16% vs 0% ), constipation (12% vs 9%), cough (12% vs 9%), bronchitis (12% vs 0%), rash (12% vs 9%),  and decreased  appetite  (12% vs 9%).

Please see the BANZEL Full Prescribing Information.

About Eisai Inc.

At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.

Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US.

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SOURCE Eisai Inc.