Actelion’s Almorexant Meets Primary Endpoint In Phase III Study

Actelion has said that the first phase III study with Almorexant (Restora 1) 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).

The finding was highly significant (p<0.001). In addition, several secondary endpoints of the study were met with statistical significance.

In Restora 1, 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. 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.

Jean-Paul Clozel, MD and chief executive officer of Actelion, said: “As a result of the use of an active reference arm of zolpidem 10mg in Restora 1, we have now obtained a first promising insight of the impact of our dual orexin receptor antagonist Almorexant compared to the impact of a traditional Gaba-agonist.

“Additional studies are being planned to further establish the clinical profile of Almorexant. We will explore aspects of sleep quality, absence of addiction and improved next-day performance. Chronic use studies in both adults and elderly will further evaluate the safety profile of this innovative agent.”