By Trisha Roy

(Reuters) – Japan-based drugmaker Eisai Co’s U.S. subsidiary announced on Sunday that it had received approval from the U.S. Food and Drug Administration for its insomnia treatment in adult patients.

The agency approved the drug, Dayvigo, in doses of 5 mg and 10 mg based on two late-stage studies testing the drug in patients with insomnia versus placebo for up to one month and six months, the drugmaker’s U.S. subsidiary said.

The treatment belongs to a new class of medications, which target the orexin system, joining the ranks with Merck & Co’s Belsomra, which was approved in 2014.

Dayvigo acts on the neurotransmitter system in the brain to suppress the wake drive, as opposed to existing prescription insomnia medicines, which target the sleep centers of the brain to increase the sleep drive, Eisai said.

FDA has recommended Dayvigo to be classified as a controlled substance because it can be addictive and has the potential to be abused. The recommendation has been submitted to the U.S. Drug Enforcement Administration (DEA), the company said.

Following the DEA scheduling of Dayvigo, which usually takes 90 days, Eisai plans to launch the drug by early April of 2020.

The company has already made approval submissions for Dayvigo in Japan and Canada and is currently testing the drug in other sleep disorders including in Alzheimer’s patients.

Patients on Dayvigo during the late-stage trials did not show any meaningful effect on their postural stability and memory and were balanced in their next-day activities as compared to placebo, the company said.

However, Eisai pointed some caution is to be taken while on the 10 mg dose as it may cause some difficulty in driving the next day after the medication.

Insomnia is characterized by difficulty falling asleep or staying asleep, which leads to fatigue, trouble concentrating, and irritability. It affects about 30% of the adult population worldwide, according to a survey conducted by the company.

Eisai said Dayvigo is an important addition to its rapidly growing neurology portfolio and underscores the company’s leadership in neuroscience, making it the first FDA-approved medication to report safety data over a 12-month period.

The drug should not be consumed by patients with narcolepsy. Dayvigo may lead to complex sleep behaviors and can impair daytime wakefulness.

The drugmaker plans to market the drug independently within the United States as well as worldwide and has initiated talks with potential health insurers.

Once the drug is launched, Eisai plans to provide copay cards, which are savings programs offered by drugmakers that help patients afford expensive prescription drugs by reducing out-of-pocket costs.

(This story has been refiled to correct third paragraph to say orexin, not oxerin).

(Reporting by Trisha Roy and Mekhla Raina in Bengaluru; Editing by Paul Simao)

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