Shots:
- Vanda Pharmaceuticals has reported the P-III (VP-VEC-162-3502) trial data assessing Hetlioz (tasimelteon; 20mg, PO, QD; n=20) vs PBO (n=20) in 43 adults with Delayed Sleep-Wake Phase Disorder (DSWPD)
- Trial met its 1EP, showing Hetlioz (20mg) shifted the time of sleep onset 42.5 min. earlier vs 5.4 min. shift on PBO, plus in an exploratory responder analysis, 60% vs 15% pts advanced their sleep timing onset by at least 30 min.
- The company plans to discuss these data with the US FDA & file an sNDA of Hetlioz for DSWPD
Ref: Vanda Pharmaceuticals | Image: Vanda Pharmaceuticals | Press Release
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