Investigational Dual Orexin Receptor Antagonist Almorexant Meets Primary Endpoint In Two-week Phase III Study Of Primary Insomnia

Main Category: Sleep / Sleep Disorders / Insomnia
Also Included In: Clinical Trials / Drug Trials
Article Date: 26 Dec 2009 - 0:00 PDT

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Actelion Ltd (SIX: ATLN) announced today 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.

Professor Jed Black, M.D. and VP Sleep Development at Actelion, commented: "In this two-week study, almorexant has demonstrated clinically meaningful effects on both sleep induction and sleep maintenance for patients suffering from primary insomnia. I am especially encouraged that these effects were maintained both throughout the night and throughout the 16-day treatment period."

Jean-Paul Clozel, M.D and Chief Executive Officer of Actelion, commented: "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."

Jean-Paul Clozel concluded: "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."

About the RESTORA program

Actelion has initiated a comprehensive Phase III program named RESTORA (REstore physiological Sleep with The Orexin Receptor antagonist Almorexant) to evaluate safety and efficacy of 100 and 200 mg doses in adults and elderly patients diagnosed with primary insomnia. The RESTORA program will also include dedicated profiling studies. The non-pivotal program is ongoing. The longer-term Phase III studies are in preparation.

About RESTORA 1

RESTORA 1 was a multi-center, double-blind, randomized, placebo-controlled, active reference (zolpidem), parallel-group polysomnography study to evaluate efficacy and safety of 16-day oral administration of almorexant 200mg and 100mg in adult 709 patients with chronic primary insomnia. Enrolment took place in 90 clinical study centers in Australia, Europe and Israel.

Detailed study results will be made available at upcoming scientific meetings or through publication in peer-reviewed scientific journals.

Source
Actelion Ltd

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