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  • greatdayforinvestments greatdayforinvestments May 4, 2013 8:08 PM Flag

    WHY AVP-923 will make billions! May 2012: Alzheimer's drug memantine fails to reduce significant agitation

    Alzheimer's drug memantine fails to reduce significant agitation
    Article | 03 May 2012 Print This ShareThis
    Memantine, a drug prescribed for Alzheimer's disease, does not ease clinically significant agitation in patients, according to a new study conducted by researchers from the UK, USA and Norway. This is the first randomized controlled trial designed to assess the effectiveness of the drug for significant agitation in Alzheimer's patients.

    Memantine, sold under the trade name Ebixa by originator Lundbeck, generated sales of 763 million ($136 million) for the Danish firm in the first quarter of this year, and $393 million for the three months to end March for US licensee Forest Laboratories, which uses the band name Namenda.

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    Previous studies suggested memantine could help reduce agitation and improve cognitive functions such as memory. Led by the University of East Anglia in the UK, the new research found that, while memantine does improve cognitive functioning and neuropsychiatric symptoms such as delusion, mood and anxiety, it is no more effective in reducing significant agitation than a placebo.

    "Memantine is quite commonly prescribed for Alzheimer's disease in the USA. Despite the negative findings regarding agitation, this trial opens a door of hope," said Regenstrief Institute investigator Malaz Boustani, associate professor of medicine at the Indiana University School of Medicine and associate director of the IU Center for Aging Research.

    Drug does help with some symptoms of AD

    "Memantine does appear to help with other behavioral and psychological symptoms of Alzheimer's disease," added Dr Boustani, a co-author of the study and also the medical and research director of the Healthy Aging Brain Center at Wishard Health Services.

    Sentiment: Strong Buy

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    • "Previous studies suggested memantine could help reduce agitation and improve cognitive functions such as memory. "
      No studies have suggested dex/quin helps with agitation or memory. So even with such a perceived signal in previous studies, there is apparently now some indication it was a false signal in memantine's case. Given that dex/quin is being studied now by Avanir as a shot in the dark, I don't think this memantine study should give cause to think dex/quin works for agitation in dementia.
      Hint, Greatday, just because the CEO spouts that a small signal of efficacy for agitation in MS and ALS patients who are having their PBA effectively treated means there is "strong proof of concept for agitation in dementia" that does not mean there is strong proof of concept for agitation in dementia.
      In fact there is no proof of concept, there is no signal.
      Wise up.

      • 1 Reply to rayonman1
      • We shall all know more in the months ahead; Pipeline In A Pill:
        KEEP IN MIND: Aug 14, 2012
        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.

        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

    • The study, titled Efficacy of memantine for agitation in Alzheimer's dementia: a randomized double-blind placebo controlled trial, was published in PLoS ONE on May 2. Authors of the study are from Indiana University; the University of East Anglia, University College London, University of Kent, Aston University, Oxleas National Health Service Foundation Trust and Kings College London, all in the UK; and the University of Stavanger in Norway.

      An estimated 5.4 million Americans have Alzheimer's disease according to the Alzheimer's Association. Many are agitated. They may, for example, pace continually, become physically or verbally aggressive or scream persistently. In addition to harming quality of life for the patient, agitation places enormous strain on relationships with family members and care providers, and often results in institutionalization.

      "People who have mild symptoms [of agitation] often respond to changes in the environment or psychological treatment, but these methods are impractical in severe agitation," said Chris Fox, of Norwich Medical School at University of East Anglia, who led the research. "Our findings regarding memantine are disappointing with respect to severe agitation - particularly as the alternative antipsychotic medications can have significant side effects such as increased rates of stroke and death. However, we hope our study will highlight the urgent need for investment in safe and effective new treatments for this growing disease."

      The team of researchers studied 153 nursing home residents and hospital in-patients with severe Alzheimer's from September 2007 to May 2010. All the study participants displayed significant agitation requiring clinical treatment. Half were given memantine, and half received a placebo. The researchers reported significant improvement in cognitive function and for overall neuropsychiatric symptoms for the group given memantine, but no statistically significant difference in terms of the severe agitation that was the primary focus of the study.

      Sentiment: Strong Buy