HONG KONG – Tokyo-headquartered Eisai Co. Ltd. is targeting new markets for its orexin receptor antagonist, Dayvigo (lemborexant), to treat insomnia. The company launched the drug in Japan on July 6, alongside a new fine granule formulation for its antiepileptic drug, Fycompa (perampanel hydrate).

An Eisai spokesperson told BioWorld the company is “aiming to expand [Dayvigo] availability to other regions,” while the launch of Fycompa’s fine granule formulation was limited to the Japanese market. The spokesperson also confirmed that both drugs were not being developed under partnerships.

Eisai shares shot up to ¥8622 (US$80.1693) on July 6, before jumping to ¥8,948 on July 9.

The COVID-19 pandemic, and Japan’s subsequent declaration of a state of emergency, proved a hurdle for the company to overcome on the path to the product launch. The spokesperson said the two products were originally scheduled to be launched separately, but the company chose the July 6 date “in order to be able to carry out sufficient information provision activities,” the source added. The process included in-person visits to hospitals to present data to doctors.

Fycompa is an antiepileptic drug discovered and developed by Eisai. The highly selective, noncompetitive AMPA receptor targets glutamate activity that mediates seizures, thereby reducing the neuronal hyperexcitation associated with them.

It has been approved for use in more than 65 countries and territories as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in epilepsy patients 12 and older. It is approved for the same indication in patients 4 and older in Japan and the U.S.

The drug is also approved in more than 60 countries to treat patients 12 and older for primary generalized tonic-clonic seizures.

The company is currently seeking approval in Europe for Fycompa as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures for pediatric epilepsy patients. The company also is in the middle of phase III trials for patients with seizures associated with Lennox-Gastaut syndrome.

The drug is available in oral suspension as well as tablet forms, both of which are approved for use in the U.S. and Europe. The latest fine granule formulation was approved in January, and added to Japan’s National Health Insurance drug price list in April. Eisai has priced a 100-gram bottle of the fine granule formulation at ¥106,890.

There are an estimated 1 million patients suffering from epilepsy in Japan, a high percentage of whom are children and the elderly. The fine granule formulation was developed so that those patients, a large number of whom have difficulty swallowing tablets, can ingest the drug with more ease. The new formulation also allows patients to control the dosage of the medicine to match the severity of their symptoms. Eisai is currently developing an injection formulation to further expand patients’ options.

Dayvigo. Credit: Eisai Co. Ltd.

Dayvigo is an insomnia treatment also discovered and developed in-house by Eisai. The drug is a dual orexin receptor antagonist that binds competitively to two subtypes of orexin receptors, inhibiting the orexin neurotransmission that regulates sleep-wake rhythms. The drug was cleared in January, on the back of the SUNRISE 1 and SUNRISE 2 phase III studies. Adult patients with insomnia were also studied for residual effects such as waking up in the middle of the night, postural stability the following morning and memory function.

The SUNRISE 1 trial involved patients in North America and Europe, while SUNRISE 2 involved patients globally, including Japan, North America, South America, Europe, Asia and Oceania. Results from both trials suggested that Dayvigo was not associated with rebound insomnia. Eisai launched the drug in June for adult insomnia patients in the U.S., and has applications in Canada and Australia pending.

The drug is available as 2.5-mg, 5-mg and 10-mg tablets, with 100-tablet boxes priced at ¥5,730, ¥9,080 and ¥13,620, respectively.

Meanwhile, Eisai removed the weight-loss drug Belviq (lorcaserin) from the U.S. market earlier in the year. The removal followed an FDA request to withdraw both Belviq and Belviq XR due to an increased risk of cancer associated with the drug. Despite the company’s separate assessment showing a different, “positive benefit-risk profile in the patient population for which they are indicated,” the company said it cooperated in the withdrawal process.

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