Eisai's Antiepileptic Drug Perampanel Oral Suspension Approved in China for the First Time

On May 17, the NMPA website announced that Eisai's Perampanel Oral Suspension has been approved for marketing in China. It is indicated for the treatment of partial-onset seizures (with or without secondary generalization) in adults and children aged 4 years and above. This approval marks the first market launch of Perampanel Oral Suspension in China.

Epilepsy is one of the most common and severe neurological disorders, characterized as a clinical syndrome caused by highly synchronized abnormal discharges of neurons in the brain due to various causes. Epidemiological studies show that the prevalence of epilepsy in China is as high as 7%. Epilepsy is difficult to cure, has a high disability rate, and requires a long treatment cycle; many patients with epilepsy need to take medication for life.

AMPA-type glutamate receptors are widely distributed in the central nervous system and play an important role in the pathogenesis of epilepsy. Inhibiting the activity of postsynaptic AMPA receptors can affect the activity of the excitatory neurotransmitter glutamate, thereby reducing neuronal hyperexcitability and achieving therapeutic effects. Therefore, AMPA receptor antagonists have the potential for broad-spectrum antiepileptic effects.

Perampanel (Fycompa) is a highly selective, non-competitive AMPA receptor antagonist that exerts its antiepileptic effects by non-competitively binding to AMPA receptors on the postsynaptic membrane, thereby inhibiting glutamate-induced excessive neurotransmission.

In July 2012, perampanel was first approved in Europe as an adjunctive treatment for partial-onset seizures in epilepsy patients aged 12 years and older. This indication was approved in the United States in October 2012. In September 2019, perampanel was approved for the first time in China for adjunctive treatment in epilepsy patients aged 12 years and older with partial-onset seizures (with or without secondary generalized seizures). In July 2021, the drug was again approved for the treatment of partial-onset seizures in adults and children aged 4 years and older (with or without secondary generalized seizures).

Eisai's official website shows that perampanel has been approved for marketing in more than 70 countries and regions worldwide. In addition to tablets, the approved formulations of perampanel also include oral suspension and fine granules.

Perampanel Global Sales (Source: PharmaCube NestPharma Database)

According to Eisai's financial report, since its launch in 2012, the global sales of Perampanel have increased year by year, reaching 31.9 billion yen (approximately 244 million U.S. dollars) in the fiscal year 2021.

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