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Avanir Pharmaceuticals, Inc. Message Board

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  • rayonman1 rayonman1 Jan 18, 2013 11:22 PM Flag

    Ray - What do you think the ratio of...

    Hi Rim,
    Always great to have you here.
    You bring up the excellent point that Alzheimer's patients with PBA are apparently NOT being excluded from the agitation in Alzheimer's study!

    If agitation in dementia ever gets to the point of an End of Phase 2 meeting, and if there are patients with PBA in the agitation in dementia studies--I think the FDA is going to largely discount
    any alleged efficacy.
    I note that PBA is NOT included in the Exclusion Criteria, as per the clinicaltrials gov site

    "Key Exclusion Criteria:

    Patient has other type of dementia (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia).

    Patients with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g. malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, certain cardiac conduction abnormalities including QTc prolongation, or unstable valvular heart disease).

    Patients with myasthenia gravis."