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Avanir Pharmaceuticals, Inc. Message Board

  • greatdayforinvestments greatdayforinvestments Apr 28, 2013 10:30 AM Flag

    Fellow Longs (KEEP IN MIND) regarding AVP-923 Alzheimer’s Disease Agitation:

    Feb 7, 2013
    Turning onto the study of AVP-923 for the treatment of vaccination in patients with Alzheimer’s disease, the study is now is well underway with study sites actively enrolling patients. Investigators, potential participants and their families remain highly interested in this study further underscoring the tremendous unmet needs of this condition.

    Aug 14, 2012

    But turning to agitation in Alzheimer’s, many people don't recognize how large of an opportunity this is with over 5 million patients suffering from Alzheimer’s and a very high percentage of them suffering from agitation at some point during their disease, a very, very significant market opportunity.

    So first starting off with agitation, we recently submitted our IND for agitation indication with the FDA and received approval to go ahead and move right into a Phase 2 clinical study. Now the IND was supported by the data that you see here in this slide, which was data that was generated in our Phase 3 studies for pseudobulbar affect.

    And what we had in our Phase 3 studies for PBA was it's called the NPI, or the neuropsych inventory and this is a measure of behavioral disturbances and the impact of behavioral disturbances and patients with ALS and MS also do tend to have behavioral disturbances and this looks just at agitation.

    And what you can see here on this slide is that at baseline, about 13 patients per treatment arm had agitation (audio gap) at the end of the study and you can see in both of the AVP 923 treatment arms we had a very dramatic reduction in the number of patients having moderate to severe agitation, approximately a 60% reduction and an increase in the number of patients suffering from these agitated episodes.

    Sentiment: Strong Buy

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    • Look forward to getting an update on the Ph 2 clinical trials this coming week!

      Sentiment: Strong Buy

    • At the Roth Conference, Avanir had in their slide deck $1 billion revenue potential from Alzheimer's Agitation!

      Sentiment: Strong Buy

    • Update this coming week from the Shareholder Update conference call!

      Sentiment: Strong Buy

    • $1 billion dollar sales estimate was the number given on the most recent slide at the Roth Conference!

      Sentiment: Strong Buy

    • greatdayforinvestments greatdayforinvestments Apr 28, 2013 10:30 AM Flag

      So this gives us very strong proof of concept moving into our Phase 2 study in agitation in Alzheimer’s patients. So that study, we plan on enrolling the first patient by the end of this calendar quarter, so by the end of September. It'll be a two arm study and it'll be AVP 923 starting at a dose of 20/10.

      That's 20 milligrams of dextromethorphan combined with 10 milligrams of quinidine, our current FDA-approved dose, and the patients' dose will be escalated to 30 milligrams of dextromethorphan and 10 milligrams of quinidine. Approximately 200 patients, roughly 100 patients per arm and you can see a number of efficacy endpoints there, the primary endpoint being the agitation sub-scale of the MPI.

      But also would draw your attention to some cognitive endpoints and given the clinical literature that's out there for MNDR receptor antagonists and the success of products like memotine, we're very interested to see the outcome of NUEDEXTA not only on agitation but also potential cognitive benefits in this population, as well.

      Sentiment: Strong Buy

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