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Saturday, November 5, 2011

Avanir enrolls first patient in Prime study for Neuropathic pain

Nov 4, 2011



Avanir Pharmaceuticals has enrolled first patient in Prime study of AVP-923 to treat central neuropathic pain in patients with multiple sclerosis (MS).

The double-blind, multicenter, placebo-controlled, randomized study is designed to assess the safety, tolerability, and efficacy of AVP-923.

The primary efficacy endpoint will be measured based on the Numeric Pain Rating Scale as recorded in patient diaries.

Secondary assessments include measures of fatigue, impact of MS on daily life, sleep quality, cognition and depression.

Avanir research and development senior vice president Joao Siffert said in addition, they look forward to explore the potential of AVP-923 across a broad range of other CNS disorders.




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The Multiple Sclerosis Society-UK, says cancer should not receive special funding

The Multiple Sclerosis Society-UK, says cancer should not receive special funding as it takes resources away from other diseases.

Laura Weir, head of policy and campaigns at the MS Society, said the UK government’s flagship Cancer Drugs Fund – which injects an extra £200 million a year to subsidise drugs in England either awaiting or not recommended by NICE – was unfair to patients with other diseases.
She said: “It is estimated that the Cancer Drugs Fund will displace £480 million from other patients in the NHS – is this a fair use of resources to help drive forward the uptake of innovative medicines across other disease areas – I don’t think it is.”
She was speaking at the ABPI’s conference in London, which sought to showcase the strength of R&D and innovation in the NHS and pharma
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Disclaimer:  'MS Views and News' (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.
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Study Finds Signs of Progression to Clinically Definite MS

AMSTERDAM – Progression from clinically isolated syndrome to clinically definite multiple sclerosis in patients who do not receive early disease-modifying treatment can be predicted by several features on brain MRI and oligoclonal band positivity, according to findings from the MSBase Registry.
Only one factor – the presence of one or more gadolinium-enhancing (GdE) T1 lesions – was a significant predictor of clinically definite MS (CDMS) in patients who received early disease-modifying therapy (DMT) after experiencing clinically isolated syndrome (CIS), Dr. Claire Meyniel reported at the joint triennial congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS).
"When facing a patient with CIS, the main point is to know whether or not he or she will develop clinically defined MS," said Dr. Meyniel of the neurology department at the University Hospital Nantes (France).
Predicting which patients with CIS will progress to CDMS has often been difficult, but progress in the diagnosis of MS with MRI during the past 10 years, including recently revised McDonald criteria (Ann. Neurol. 2011;69:292-302), have simplified diagnostic criteria for MS without compromising their specificity, she said.


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MRI Predicts Response After Starting MS Treatment

AMSTERDAM – MRI of the brain performed 1 year after starting disease-modifying treatment for relapsing-remitting multiple sclerosis predicted response to treatment at 5 years in a retrospective, observational, single-center study.
Several other baseline predictors of a better response to disease-modifying treatment (DMT) at 5 years included male sex, a low EDSS (Expanded Disability Status Scale) score, the presence of monofocal disease, and fewer gadolinium-enhancing (GdE) T1-weighted lesions on MRI.
Previous studies have found that MRI performed 1 year after initiation of DMT can predict treatment response in the subsequent 2-3 years (Eur. J. Neurol. 2009;16:1202-9Mult. Scler. 2009;15:848-53). But Dr. Marzia Romeo, the lead investigator of the current study, and her colleagues sought to determine if it could also predict longer-term outcomes.
"One of our many issues is to identify patients who benefit from first-line therapy for MS," said Dr. Romeo of the San Raffaele Hospital in Milan at the joint triennial congressof the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS)...
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Disclaimer:  'MS Views and News' (MSVN), does not endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, and procedures for your personal knowledge and to keep you informed of current health-related issues. It is not intended to be complete or exhaustive, nor is it a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.
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Friday, November 4, 2011

Oral Laquinimod Unfortunately on hold


November 3, 2011
Laquinimod filing would be 'premature'
Teva chief executive Shlomo Yanai also caused a bit of a stir by revealing that the company is holding off on filing laquinimod, developed with Sweden's Active Biotech, in the USA.
He noted that the company met with the US Food and Drug Administration last week to discuss the New Drug Application for the late-stage oral MS drug and following the meeting, he said "we now believe that it would be premature to file the NDA at this time". Mr Yanai added that "the FDA has offered to work with us to determine the best design for conducting an additional trial".
Mr Clark told PharmaTimes World News that the decision to put the submission on hold was "prudent". In August, initial results from the Phase III BRAVO study, the second of two late-stage trials on laquinimod, showed that the drug failed to meet its primary endpoint of reducing the annualised relapse rate when compared with placebo.
However, at the time, Teva noted that the placebo and treatment study groups showed dissimilarity "in two baseline magnetic resonance imaging" characteristics and following a "pre-specified sensitivity analysis", when this imbalance was corrected, laquinimod demonstrated a significant reduction in the annualised relapse rate (21.3%) in the risk of disability progression and in brain volume loss (27.5%).
In the summer, the company still felt confident that an adjustment of the data would be enough to support a filing but Mr Clark said "this was not something upon which we expected the FDA would look favourably". That, "in conjunction with the lack of overwhelmingly positive data previously", led the analyst to "remove estimates for laquinimod from our model some time ago". Mr Clark concluded by praising Teva management's decision "to deploy their resources in the most sensible way possible and, for now, that means holding off on laquinimod".

Source: Pharma Times


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Thursday, November 3, 2011

MS Patients Perceive Copaxone Efficacy


CAMBRIDGE, MA--(Marketwire - Nov 3, 2011) - In the second report of a series on Multiple Sclerosis (MS) disease modifying therapies (DMTs), PatientsLikeMe reveals that MS patients perceive Copaxone as having comparable efficacy and tolerability profiles to the interferon therapies Avonex and Rebif. However, all three medications are perceived as trailing in efficacy and tolerability to Gilenya, Tysabri and Betaseron. In the report's analysis of 3,200+ patient conversations about MS DMTs from January-June this year, PatientsLikeMe also finds that Copaxone is perceived as safer than other MS DMTs.
"Patients' sharing of their Copaxone experience may adversely affect its demand as a first line therapy since patients are becoming more influential in their treatment decisions," says David S. Williams III, Chief Marketing Officer at PatientsLikeMe. "What has become clear through these reports is that real-world evidence will have a major impact on relative pricing for MS DMTs and play an increasingly important role in access decisions."
This 46-page report -- titled "Does Copaxone patient experience in the real world justify its value?" -- quantitatively and qualitatively analyzes 4,100+ MS patients with experience using Copaxone. Other report sections include:
  Click to continue with this read
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