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Avanir Pharmaceuticals, Inc. Message Board

  • greatdayforinvestments greatdayforinvestments Apr 28, 2013 10:19 AM Flag

    Fellow Longs (KEEP IN MIND) regarding AVP-786 and PRIME study:

    Feb 7 2013:

    We are currently running the second stage of this Phase I study to explore whether we can further reduce the amount of quinidine necessary for achieving the high plasma levels. With this data in hand, we plan on meeting the FDA to determine the full development program of AVP-786.

    Given these very encouraging results with 786, we have made the decision to accelerate the completion of the PRIME study which is the studies of both candidates AVP-923 and neuropathic pain related to Multiple Sclerosis because we believe that 786 would be a preferable investigational compound for the development in neuropathic pain. Changing the enrollment targets for the PRIME study to 200 patients will allow us to generate those response data earlier and provide useful guidance for the development of AVP-786. We now anticipate that we’ll have top line data from the PRIME study in the fourth quarter of calendar 2013.

    Sentiment: Strong Buy

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    • greatdayforinvestments greatdayforinvestments Apr 28, 2013 10:21 AM Flag

      Earlier today, we announced very good news regarding the development of AVP-786 which is our new compound containing the deuterium-modified dextromethorphan. Based on this exciting interim data, we believe we have identified a formulation of AVP-786 with a comparable pharmacokinetic safety and tolerability profile of AVP-923 which is used as control in this study.

      Combining AVP-786 with a substantially lower dose of quinidine, we were able to successfully replicate the steady-state plasma levels of AVP-923 with comparable safety in this study. We believe there is a reduction in quinidine in significant amount that it could potential result in meaningful changes pertaining to quinidine related language in the package insert for AVP-786.

      Indeed if you look at the slide depicting the pharmacokinetic profile of the AVP-786 which was slide 22 in the corporate presentation posted on the Avanir website, you can see the remarkable similarity of plasma concentration curves between AVP-786 and AVP-923. What’s excited to note too is that the amount of deuterium-DM and the amount of DM that yielded this curve are exactly the same.

      The only difference being that the two formulation of the AVP-786 has a substantially lower dose of quinidine. Giving these results, we plan on testing AVP-786 in one or more of our ongoing clinical programs. In addition, the knowledge we have accumulated during the development of NUEDEXTA provides us with a unique insight that positions Avanir to efficiently advance the AVP-786 development.

      We are currently running the second stage of this Phase I study to explore whether we can further reduce the amount of quinidine necessary for achieving the high plasma levels. With this data in hand, we plan on meeting the FDA to determine the full development program of AVP-786.

      Given these very encouraging results with 786, we have made the decision to accelerate the completion of the PRIME study which is the studies of both candidates AVP-923 and neuropat

      Sentiment: Strong Buy

 
AVNR
5.28-0.04(-0.75%)Jul 22 4:00 PMEDT

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