TOKYO, Japan I January 5, 2015 I Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that a Phase III clinical trial (Study 335) of its in-house-discovered antiepileptic drug (AED) perampanel (generic name, U.S. and Europe brand name: Fycompa®) in patients with refractory partial-onset seizures conducted in Asia (including Japan and China) has met its primary endpoint.
Study 335 was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of adjunctive perampanel therapy in 710 patients aged 12 years and older with refractory partial-onset seizures conducted in Asia.
The primary endpoint of the study was change in seizure frequency (percent change in seizure frequency per 28 days during treatment relative to baseline). Preliminary analysis of the study confirmed that perampanel statistically significantly reduced seizure frequency at doses of 8 mg/day and 12 mg/day, which demonstrated a greater improvement in seizure frequency when compared to placebo. Furthermore, the most common adverse events (>15% in the perampanel arms and greater than placebo) were dizziness and somnolence. The adverse event profile observed in the study was similar to that observed in other perampanel studies.
Perampanel is a first-in-class AED discovered and developed by Eisai. With epileptic seizures being primarily mediated by the neurotransmitter glutamate, the agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. Perampanel is approved as an adjunctive treatment for partial-onset seizures (with or without secondary generalized seizures) in patients with epilepsy aged 12 years and older in more than 40 countries primarily in Europe and North America, and has been launched in over 15 countries.
Furthermore, regarding the adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures, one of the most severe forms of generalized seizures, applications for indication expansion based on a global Phase III study (Study 332) have been submitted in Europe and the United States. In Japan, Eisai has already submitted a part of the submission package, including data from the clinical studies conducted in Europe and the United States, to the Pharmaceutical and Medical Devices Agency based on the prior assessment consultation system* with the aim of shortening application review time. With the submission of additional data from Study 335 and Study 332, Eisai plans to submit a new drug application covering refractory partial-onset seizures as well as PGTC seizures in Japan during the first half of fiscal 2015.
Eisai considers neurology as a therapeutic area of focus and is committed to the development of treatments such as perampanel, through which it seeks to make further contributions to addressing the diverse needs of, as well as increasing the benefits provided to, epilepsy patients and their families.
*The prior assessment consultation system is conducted at the development stage before new drug application submission based on available quality, non-clinical and clinical data. By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time as a result.
SOURCE: Eisai
Post Views: 129
TOKYO, Japan I January 5, 2015 I Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that a Phase III clinical trial (Study 335) of its in-house-discovered antiepileptic drug (AED) perampanel (generic name, U.S. and Europe brand name: Fycompa®) in patients with refractory partial-onset seizures conducted in Asia (including Japan and China) has met its primary endpoint.
Study 335 was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of adjunctive perampanel therapy in 710 patients aged 12 years and older with refractory partial-onset seizures conducted in Asia.
The primary endpoint of the study was change in seizure frequency (percent change in seizure frequency per 28 days during treatment relative to baseline). Preliminary analysis of the study confirmed that perampanel statistically significantly reduced seizure frequency at doses of 8 mg/day and 12 mg/day, which demonstrated a greater improvement in seizure frequency when compared to placebo. Furthermore, the most common adverse events (>15% in the perampanel arms and greater than placebo) were dizziness and somnolence. The adverse event profile observed in the study was similar to that observed in other perampanel studies.
Perampanel is a first-in-class AED discovered and developed by Eisai. With epileptic seizures being primarily mediated by the neurotransmitter glutamate, the agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors. Perampanel is approved as an adjunctive treatment for partial-onset seizures (with or without secondary generalized seizures) in patients with epilepsy aged 12 years and older in more than 40 countries primarily in Europe and North America, and has been launched in over 15 countries.
Furthermore, regarding the adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures, one of the most severe forms of generalized seizures, applications for indication expansion based on a global Phase III study (Study 332) have been submitted in Europe and the United States. In Japan, Eisai has already submitted a part of the submission package, including data from the clinical studies conducted in Europe and the United States, to the Pharmaceutical and Medical Devices Agency based on the prior assessment consultation system* with the aim of shortening application review time. With the submission of additional data from Study 335 and Study 332, Eisai plans to submit a new drug application covering refractory partial-onset seizures as well as PGTC seizures in Japan during the first half of fiscal 2015.
Eisai considers neurology as a therapeutic area of focus and is committed to the development of treatments such as perampanel, through which it seeks to make further contributions to addressing the diverse needs of, as well as increasing the benefits provided to, epilepsy patients and their families.
*The prior assessment consultation system is conducted at the development stage before new drug application submission based on available quality, non-clinical and clinical data. By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time as a result.
SOURCE: Eisai
Post Views: 129
