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Release issued 15th March 2005
Amarin announced positive data analysis from a third exploratory phase IIa clinical trial using Miraxion to treat depression. Miraxion was used as adjunct therapy (with either SSRIs or tricyclics) in 115 patients with treatment- unresponsive depression in a 12-week double blind, placebo controlled clinical trial. The Hamilton Depression Rating Scale (HDRS) was used as the primary efficacy measure. Although in the whole group Miraxion did not show a significant difference over placebo, an exploratory analysis demonstrated significant superiority (p < 0.05) in the subgroup of depression patients (n = 70) with melancholic characteristics using a repeated measurements design.
This sub-group of depression patients was defined by using select criteria from DSM-IV (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition) which is the main diagnostic reference of Mental Health professionals in the United States of America, published by the American Psychiatric Association, Washington D.C. Identical methodology was used to identify melancholic depression patients in the previously announced data analysis from the 77 patient monotherapy trial and the 70 patient adjunct therapy depression trial. The data from all three trials are consistent and show a significant clinical benefit using Miraxion in patients with depression with melancholic characteristics.
On 12th January 2005, Amarin announced data from a monotherapy clinical trial using Miraxion alone to treat depression patients. The monotherapy trial included 77 patients, of whom 39 patients were identified with melancholic depression characteristics. In this group, statistical significance (p=
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(28th July 2006) Amarin Completes Target Patient Enrollment in European Phase III Trial of Miraxion in Huntington's Disease
(19th July 2006) Amarin Completes Target Patient Enrollment in North American Phase III Trial of Miraxion in Huntington's Disease
(17th May 2006) AMARIN ACQUIRES PARKINSON'S DISEASE DRUG CANDIDATE
(8th March 2006) AMARIN CORPORATION PLC REPORTS MIRAXION IMPROVES STRESS HORMONE TRANSPORT THROUGH THE BLOOD BRAIN BARRIER IN PRE-CLINICAL STUDIES
(10th January 2006) AMARIN REPORTS PRELIMINARY RESULTS FROM PARKINSON'S DISEASE PRE-CLINICAL PROGRAM USING MIRAXION