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 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.
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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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