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Vanda Pharmaceuticals Announces Positive Phase III Results for HETLIOZ®(tasimelteon) in Delayed Sleep-Wake Phase Disorder
- Vanda Pharmaceuticals reported positive topline results from a Phase III study testing HETLIOZ® in adults with Delayed Sleep-Wake Phase Disorder.
- The study met its primary endpoint, with HETLIOZ® shifting sleep onset 42.5 minutes earlier compared with 5.4 minutes for placebo.
- In an exploratory analysis, 60% of participants receiving tasimelteon advanced sleep onset by at least 30 minutes, compared with 15% receiving placebo.
- Vanda plans to discuss the results with the U.S. Food and Drug Administration and seek approval for HETLIOZ® for this use.
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Vanda Pharmaceuticals Announces Positive Phase III Results for HETLIOZ®(tasimelteon) in Delayed Sleep-Wake Phase Disorder
Study met its primary endpoint: timing of sleep onset shifted 37.1 minutes earlier versus placebo (p=0.022)60% of HETLIOZ® treated participants shifted sleep at least 30 minutes earlier, compared to 15% of the placebo arm
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Leaning Left4Leaning Right2Center6Last UpdatedBias Distribution50% Center
Bias Distribution
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50% Center
L 33%
C 50%
R 17%
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