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 Vanda Pharmaceuticals Inc. won U.S. marketing approval for Hetlioz (tasimelteon)
last year as a treatment for what’s known as non-24-hour sleep-wake
disorder, or “non-24,” a chronic circadian rhythm problem that’s
common among blind people who don’t have the benefit of light to
synchronize their body clocks to the outside world.
“The treatment needs to be taken every 24 hours, at a fixed clock
time each day, in order to provide the replacement daily time cue
usually provided by the 24-hour light-dark cycle,” lead author of
the studies, Dr. Steven Lockley of Harvard Medical School, said by
email.
European regulators approved the pill last month for totally blind
people with non-24. According to the U.S. Food and Drug
Administration, the drug stimulates the same cellular receptor as
the popular supplement melatonin.
The pill won clearance in the U.S. and Europe under accelerated
review processes allowed for so-called orphan drugs that treat
serious, rare conditions with limited treatment options. Among other
things, orphan drug status can allow companies to seek clearance
with smaller, faster clinical trials.
In the two studies Vanda used to seek marketing approval for Hetlioz,
Lockley and colleagues examined the effectiveness of the drug in 104
totally blind patients at 27 clinical trial centers in the U.S. and
Germany.
In the first experiment, researchers asked 84 blind people with
non-24 to take a pill roughly one hour before bedtime, giving half
of them Hetlioz and half a placebo, or dummy pill.
Among 40 patients who remained on the drug throughout the study,
eight achieved normal sleep patterns, compared with one out of 38
people on placebo.
For the second test, researchers selected 20 blind people with
non-24 who achieved normal sleep rhythms with the drug and compared
what happened when half of them stayed on the pill while the other
half had it replaced with a placebo.
Nine of 10 people who remained on the drug retained normal sleep
rhythms, compared with two people on placebo.
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During the two studies, both published in The Lancet, the most
common side effects of Hetlioz were headaches, elevated liver
enzymes, nightmares or abnormal dreams and infections of the upper
respiratory and urinary tracts.
Hetlioz may cost up to $60,000 a year or more, so some patients with
non-24 may want to consider nonprescription melatonin supplements
that typically cost up to $50 a year, suggested Charmane Eastman in
a commentary accompanying the study. Eastman is a scientist at the
biological rhythms research lab at Rush University Medical Center in
Chicago.
Melatonin has long been a standard and effective treatment option
for non-24, but no head-to-head trials have compared this supplement
to prescription Hetlioz, Eastman said by email.
“The drug company is not going to do a study to compare the two
because it’s not profitable and it is likely that there would be no
difference,” Eastman said.
Patients who do choose melatonin for non-24 should be sure to take
it at the same time each day, three to five hours before bedtime,
and stick to it consistently, she advised.
“It may take months to synchronize your internal body clock to the
24-hour day,” Eastman added.
SOURCE: http://bit.ly/1N7ihob The Lancet, online August 4, 2015.
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