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Date: 2009-12-21
Phase: III
Anouncement: Result
Biotech: Actelion (Switzerland)
Pharma: GSK (UK)
Product: almorexant (dual orexin receptor antagonist)
Disease: primary insomnia
Country:
Other: The first phase III study (a two-week phase III study) with almorexant (RESTORA 1 - See clinical_studies) has met its primary endpoint, superiority of the dual orexin receptor antagonist almorexant compared to placebo on objective and subjective wake after sleep onset (WASO).

Several secondary endpoints of the study were met with statistical significance.the use of almorexant was well-tolerated. However, in this study as well as in the ongoing non-pivotal program, certain safety observations were made that will require further evaluation and assessment in longer-term Phase III studies.

In RESTORA 1, the Phase III studies are currently in preparation - in both adults and elderly patients suffering from primary insomnia - and will evaluate long-term efficacy and safety.
Additional studies are being planned to further establish the clinical profile of almorexant.