Hoffnung für Patienten mit schweren Depressionen?
Miraxion, ein halbsynthetisches, hoch gereinigtes Derivat der dreifach ungesättigten Eicosapentaensäure (EPA), hat in einer Phase-II-Studie bei der Behandlung von Patienten mit schweren Depressionen positive Ergebnisse erzielt, wie das Biotechnologieunternehmen Amarin meldete.
Miraxion wurde als Monotherapiepräparat bei 77 Patienten in einer klinischen Phase-II-Studie getestet. Die Probanden wiesen zu Beginn dieser Behandlung schwere melancholisch-vegetative Symptome auf und sprachen auf herkömmliche Medikamente nicht mehr an. Es wird geschätzt, dass ungefähr 20 bis 30% aller Patienten mit Depressionen unter dieser schweren Form leiden. Wie die Analysen der Studie ergaben, konnten nach sechswöchiger Behandlung der Patienten mit Miraxion erste positive Veränderungen der Symptome verzeichnet werden. Die vollständigen Resultate der Phase-II-Monotherapiestudie werden von Amarin noch im Laufe dieses Jahres erwartet.
Wirkmechanismus ungeklärt
Der Wirkmechanismus von Miraxion bei der Behandlung der schweren Depression ist noch nicht genau bekannt. Er unterscheidet sich jedoch von dem der typischen und atypischen Antidepressiva und selektiven Serotonin-Wiederaufnahmehemmer. Es wird angenommen, dass die Symptome und der Grad der Schwere der Depression im Zusammenhang mit einem starken Ungleichgewicht zwischen Eicosapentaensäure und Arachidonsäure stehen, in das Miraxion ausgleichend eingreift.
Bereits in einer Phase-III-Studie wurde der Wirkstoff bei der Behandlung der Huntington-Krankheit (Veitstanz) getestet, bei der es aufgrund erblich bedingter Genmutationen zu fortschreitenden Veränderungen des Gehirns bis hin zur Demenz kommt. Hier wird ein anderer Wirkmechanismus vermutet: Miraxion schein an der Stabilisierung der Mitochondrien der degenerativen Neurone beteiligt zu sein, wodurch der schleichende Zelltod aufgehalten oder verhindert wird. Für diese Indikation befindet sich Miraxion schon in der Zulassung: in den USA hat es den Fast-track-Status erhalten und in Europa und den USA den Orphan-drug-Status.
Quelle: Amarin's novel lipid could work in severe depression. scrip Nr. 3022 vom 21. Januar 2005.
http://www.deutscher-apotheker-verlag.d ... 0216d.html
Hoffnung für Patienten mit schweren Depressionen? "Miraxion"
Re: Hoffnung für Patienten mit schweren Depressionen? "Miraxion"
Hallo,
wenn das Medi schon für die Huntington-Krankheit eine Zulassung hat, müsste man es doch theoretisch auf Privatrezept bekommen!? oder nicht? Da es so aussieht als gäbe es keine schädlichen Nebenwirkungen wäre das für mich jedenfalls interessant. Meint ihr das funktioniert?
simon
wenn das Medi schon für die Huntington-Krankheit eine Zulassung hat, müsste man es doch theoretisch auf Privatrezept bekommen!? oder nicht? Da es so aussieht als gäbe es keine schädlichen Nebenwirkungen wäre das für mich jedenfalls interessant. Meint ihr das funktioniert?
simon
Re: Hoffnung für Patienten mit schweren Depressionen? "Miraxion"
Amarin Corporation Announces Additional Positive Clinical Data For Miraxion™ To Treat Unresponsive Depression
-- Consistent data in three Phase IIa clinical trials in depression patients with melancholic characteristics --
LONDON, United Kingdom, March 15, 2005 – Amarin Corporation plc (NASDAQSC: AMRN) today 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 SSRI’s 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=<0.05) was observed using the Bech scale (a sub-scale of HDRS) to measure affective core symptoms of depression. A third Phase IIa clinical trial with 70 treatment-unresponsive depression patients was also re-analyzed using identical symptom-specific methodology identifying 28 melancholic depression patients. Statistically significant data were again observed, using HDRS, from the reanalysis of the dataset from this published (Peet and Horrobin, 2002, Archives of General Psychiatry, volume 59, pages 913-919), randomized, placebo controlled clinical trial in treatment-unresponsive depression, where Miraxion was used as an adjunct therapy with standard depression treatments in a dose range from 1g – 4 g per day.
It is estimated that depressed patients who are unresponsive to standard treatment and have melancholic depression symptoms may represent approximately 20-30% of all patients with depression.
Amarin filed a patent covering intellectual property related to the use of Miraxion in treatment-unresponsive depression in late 2004.
Rick Stewart, Chief Executive Officer of Amarin commented, "The exploratory analyses from three Phase IIa clinical trials have shown consistent positive data in the treatment of depressed patients with melancholic characteristics. The clinical benefits to patients with melancholic characteristics include reduction in the affective core symptoms of depression, such as depressed mood and guilt. There were no sexual dysfunction side effects, which are often prevalent with standard depression treatments. This positive data allows us to more accurately target patients with depression that may respond to Miraxion. We are now planning an additional, larger confirmatory Phase II clinical trial and we are seeking a development and marketing partner for Miraxion in depression."
Quelle:
http://www.amarincorp.com/pressrelease.cfm?id=103
-- Consistent data in three Phase IIa clinical trials in depression patients with melancholic characteristics --
LONDON, United Kingdom, March 15, 2005 – Amarin Corporation plc (NASDAQSC: AMRN) today 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 SSRI’s 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=<0.05) was observed using the Bech scale (a sub-scale of HDRS) to measure affective core symptoms of depression. A third Phase IIa clinical trial with 70 treatment-unresponsive depression patients was also re-analyzed using identical symptom-specific methodology identifying 28 melancholic depression patients. Statistically significant data were again observed, using HDRS, from the reanalysis of the dataset from this published (Peet and Horrobin, 2002, Archives of General Psychiatry, volume 59, pages 913-919), randomized, placebo controlled clinical trial in treatment-unresponsive depression, where Miraxion was used as an adjunct therapy with standard depression treatments in a dose range from 1g – 4 g per day.
It is estimated that depressed patients who are unresponsive to standard treatment and have melancholic depression symptoms may represent approximately 20-30% of all patients with depression.
Amarin filed a patent covering intellectual property related to the use of Miraxion in treatment-unresponsive depression in late 2004.
Rick Stewart, Chief Executive Officer of Amarin commented, "The exploratory analyses from three Phase IIa clinical trials have shown consistent positive data in the treatment of depressed patients with melancholic characteristics. The clinical benefits to patients with melancholic characteristics include reduction in the affective core symptoms of depression, such as depressed mood and guilt. There were no sexual dysfunction side effects, which are often prevalent with standard depression treatments. This positive data allows us to more accurately target patients with depression that may respond to Miraxion. We are now planning an additional, larger confirmatory Phase II clinical trial and we are seeking a development and marketing partner for Miraxion in depression."
Quelle:
http://www.amarincorp.com/pressrelease.cfm?id=103