Eisai Launches New Fine Granule Formulation of Anti-Epileptic Drug Fycompa® in Japan; Tablet Formulation Rolled Out in China in January

July 12, 2020 News /BioValleyBIOON/ -- Eisai recently announced the launch in Japan of a new fine-granule formulation of the antiepileptic drug Fycompa (Weiketai®, generic name: perampanel, 1%, 100 g per bottle). Approved this January, this formulation will make it easier for pediatric and adult patients who have difficulty swallowing tablets to take Fycompa. Fycompa is available in multiple dosage forms and is administered orally once daily at bedtime. Its oral suspension and tablet formulations have already been approved in the United States and Europe.

Fycompa is a first-in-class antiepileptic drug (AED) developed internally by Eisai. It is a highly selective, non-competitive AMPA-type glutamate receptor antagonist. Glutamate is the primary neurotransmitter mediating seizures. As an AMPA receptor antagonist, Fycompa reduces the hyperexcitability of neurons associated with seizures by targeting the activity of postsynaptic AMPA receptors and glutamate; this mechanism of action differs from that of currently marketed antiepileptic drugs (AEDs).

To date, Fycompa has been approved in more than 65 countries worldwide, including Japan, the United States, China, and other countries in Europe and Asia, as an adjunctive therapy for the treatment of partial-onset seizures (POS), with or without secondary generalization, in patients aged 12 years and older with epilepsy. In addition, Fycompa has been approved in more than 60 countries worldwide, including the United States, Japan, Europe, and Asia, as an adjunctive therapy for the treatment of primary generalized tonic-clonic (PGTC) seizures in patients aged 12 years and older with epilepsy. In the United States and Japan, Fycompa is also indicated as monotherapy and adjunctive therapy for the treatment of partial-onset seizures, with or without secondary generalization, in patients aged 4 years and older with epilepsy. In Europe, Eisai has submitted an application seeking additional approval for Fycompa as an adjunctive therapy in pediatric patients with epilepsy for the treatment of partial-onset seizures (with or without secondary generalization) or primary generalized tonic-clonic (PGTC) seizures. To date, Fycompa has been used to treat more than 300,000 patients worldwide.

Currently, Eisai is also conducting a global Phase III clinical study (Study 338) to evaluate the efficacy of Fycompa in the treatment of epilepsy associated with Lennox-Gastaut syndrome. In addition, the company is developing an injectable formulation of Fycompa.

In China, Fycompa (WEIKETAI®, generic name: perampanel) submitted a New Drug Application (NDA) in September 2018 as an adjunctive therapy for partial-onset seizures in patients with epilepsy aged 12 years and older. Due to its significant clinical benefits over existing medications, the National Medical Products Administration (NMPA) of China granted Fycompa priority review status in January 2019 and approved it in September 2019.

In early January this year, Eisai launched Fycompa (Fycompa®) in the Chinese market. This medication is a once-daily tablet indicated as adjunctive therapy for partial-onset seizures (with or without secondary generalization) in patients aged 12 years and older with epilepsy.

It is estimated that there are approximately 9 million patients with epilepsy in China, with about 60% affected by focal seizures. Among these, 40% of patients with focal seizures require adjunctive therapy. Approximately 30% of epilepsy patients experience uncontrolled seizures despite treatment with currently available anti-epileptic drugs (AEDs), indicating a significant unmet medical need in this field.

Epilepsy can be broadly classified according to seizure type, with partial seizures accounting for approximately 60% of cases and generalized seizures for about 40%. Primary generalized tonic-clonic (PGTC) seizures, also known as grand mal seizures, are the most common and severe type of generalized seizure, representing approximately 60% of all generalized seizure cases. PGTC seizures are characterized by loss of consciousness and generalized convulsions. Common symptoms of grand mal seizures include foaming at the mouth, upward deviation of the eyes, convulsions of the limbs, and screaming; severe cases may result in urinary and fecal incontinence and status epilepticus. Seizures result from an imbalance between neuronal excitation and inhibition in the brain. These imbalances may be triggered by various neurochemical mechanisms, which remain poorly understood at present. (Bioon.com)

Original Source: NEW FINE GRANULE FORMULATION OF ANTI-EPILEPTIC DRUG FYCOMPA® LAUNCHED IN JAPAN