Following Its Launch as Adjunctive Therapy for the Treatment of Partial-Onset Epileptic Seizures, Valeant/GlaxoSmithKline’

Eisai’s Perampanel is Also Forecasted to Earn Peak Year Sales of up to $250 Million, According to Findings from Decision Resources

BURLINGTON, Mass.--(BUSINESS WIRE)-- Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that Valeant/GlaxoSmithKline’s new antiepileptic drug (AED) Potiga/Trobalt is expected to earn peak year sales of up to $250 million, following its recent launch in the United Kingdom and subsequent expected launches in the United States, France, Germany, Italy and Spain as adjunctive therapy for partial-onset seizures in adult epilepsy patients.

The Pharmacor findings from the topic entitled Epilepsy also reveal that Eisai’s emerging AED perampanel is forecasted to earn peak year sales of up to $250 million, following its expected U.S. launch next year and subsequent launches in the European markets under study and in Japan for the indication of partial-onset epilepsy. Perampanel has completed three Phase III clinical trials that will form the basis of a regulatory application for the indication of partial-onset seizures in adult epilepsy patients. Late last year, Eisai reported positive results from the first-completed Phase III trial and last month, during the 63rd Annual Meeting of the American Academy of Neurology, the company presented data from the second Phase III trial.

“Although this latter trial of perampanel did not reach statistical significance on either pre-specified primary end point, post-study analyses of different trial populations demonstrated clinical efficacy in refractory partial-onset epilepsy,” said Decision Resources Analyst Nadja Rozovsky, Ph.D. “We believe Eisai will proceed with the regulatory submission process as planned, assuming that the results from the third Phase III trial are positive, and based on the assumption that positive results from two out of three Phase III trials will be sufficient to attain regulatory approval.”

Among current AEDs, GlaxoSmithKline’s Lamictal XR recently received approval by the U.S. Food and Drug Administration (FDA) for conversion to monotherapy use in adolescent and adult epilepsy patients experiencing partial-onset seizures. The study design employed historical controls—combined pseudo-placebo arm outcomes from previously conducted, similarly designed trials of AEDs for the same indication. This approval marks the first time that such a trial design formed the basis for a U.S. regulatory submission in epilepsy and, as a result, has created a precedent for other AEDs seeking a conversion to monotherapy label in epilepsy. Most notably, such agents include Sunovion’s Stedesa which is currently in Phase III trials for conversion to monotherapy (primarily in the U.S.) and is employing historical controls in these studies.

“Although the use of placebo in epilepsy clinical trials is unethical, the FDA does not accept the use of an optimally-dosed active comparator in monotherapy clinical trials in epilepsy,” Dr. Rozovsky said. “As a result, the use of pseudo-placebo—a sub-optimally dosed AED—in such trials is common but as this practice is fraught with difficulties, the epilepsy community promoted the use of historical controls as an alternative approach in monotherapy clinical trials in epilepsy.”

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