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Hetlioz is a group of melatonin-affected exciters, melatonin is one of the hormones secreted by the brain pineal gland, secretion has a distinct circadian rhythm, day secretion is inhibited, night secretion is active, has the effect of improving sleep.
Hetlioz improved the patient's reversed circadian rhythm by agitated SMS patient melatonin-like.
the approval was based on a double-blind, placebo-controlled cross-clinical study of SMS patients (NCT 02231008), in which subjects were given Hetlioz (1h before bed) and placebo treatment for 4 weeks, stopped for 1 week, and then cross-drug.
efficacy was compared to the end point of sleep quality score and sleep length.
results showed that 50 percent of patients in the Hetlioz group had significant statistical differences in the average quality score for the nights with the worst sleep quality compared to the placebo group.
50% of the total sleep duration at night was better than that of the placebo group, but there was no significant difference.
-Magill syndrome (SMS) is a rare non-hereditary neurodevelopmental disorder caused by a small loss of 17p chromosomes.
most common symptoms are sleep disorders, which have reversed circadian rhythms and difficulty falling asleep at night, severely affecting the lives of patients and their families.
estimates that about one in every 15,000-25,000 children in the United States suffers from the disease. Dr. Mihael H. Polymeropoulos, President of
Vanda, said, "Thanks to the cooperation of SMS patients and their families, as well as the researchers and staff involved in the design and implementation of this research program, their efforts have enabled Hetlioz to be approved by the FDA, and we remain committed to providing treatment for people with SMS sleep disorders."
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