A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of ONO-2333Ms in Patients With Recurrent Major Depressive Disorder

The purpose of this study is to evaluate the safety and efficacy of ONO-2333Ms in patients with Recurrent Major Depressive Disorder

Start Date13 Jun 2007

Sponsor / Collaborator

Ono Pharma USA, Inc.

100 Clinical Results associated with ONO-2333Ms

100 Translational Medicine associated with ONO-2333Ms

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01 Mar 2013·Drug and Alcohol DependenceQ2 · MEDICINE

Behavioral, biological, and chemical perspectives on targeting CRF1 receptor antagonists to treat alcoholism

Q2 · MEDICINE

Review

Author: Heilig, Markus ; Shaham, Yavin ; Zorrilla, Eric P. ; de Wit, Harriet

BACKGROUNDAlcohol use disorders are chronic disabling conditions for which existing pharmacotherapies have only modest efficacy. In the present review, derived from the 2012 Behavior, Biology and Chemistry "Translational Research in Addiction" symposium, we summarize the anti-relapse potential of corticotropin-releasing factor type 1 (CRF(1)) receptor antagonists to reduce negative emotional symptoms of acute and protracted alcohol withdrawal and stress-induced relapse to alcohol seeking.METHODSWe review the biology of CRF(1) systems, the activity of CRF(1) receptor antagonists in animal models of anxiolytic and antidepressant activity, and experimental findings in alcohol addiction models. We also update the clinical trial status of CRF(1) receptor antagonists, including pexacerfont (BMS-562086), emicerfont (GW876008), verucerfont (GSK561679), CP316311, SSR125543A, R121919/NBI30775, R317573/19567470/CRA5626, and ONO-2333Ms. Finally, we discuss the potential heterogeneity and pharmacogenomics of CRF(1) receptor pharmacotherapy for alcohol dependence.RESULTSThe evidence suggests that brain penetrant-CRF(1) receptor antagonists have therapeutic potential for alcohol dependence. Lead compounds with clinically desirable pharmacokinetic properties now exist, and longer receptor residence rates (i.e., slow dissociation) may predict greater CRF(1) receptor antagonist efficacy. Functional variants in genes that encode CRF system molecules, including polymorphisms in Crhr1 (rs110402, rs1876831, rs242938) and Crhbp genes (rs10055255, rs3811939) may promote alcohol seeking and consumption by altering basal or stress-induced CRF system activation.CONCLUSIONSOngoing clinical trials with pexacerfont and verucerfont in moderately to highly severe dependent anxious alcoholics may yield insight as to the role of CRF(1) receptor antagonists in a personalized medicine approach to treat drug or alcohol dependence.

100 Deals associated with ONO-2333Ms

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Indication	Highest Phase	Country/Location	Organization	Date
Recurrent major depressive disorder with atypical features	Phase 2	US	Ono Pharma USA, Inc.	13 Jun 2007

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