% | $
Quotes you view appear here for quick access.

Avanir Pharmaceuticals, Inc. Message Board

  • jeanmichelwarhola jeanmichelwarhola Sep 1, 2010 11:35 AM Flag

    Avanir’s STAR trial gives clarity to the FDA for Oct 30th Decision

    Safety data for zenvia was clearly demonstrated in the STAR TRIAL and was extremely strong. There were basically no cardiovascular SAE’s. This is important because cardiovascular risks was a concern of the FDA. In the STAR Trial they took EKG’s at every office visit at peak plasma levels between 1.5 and 2.5 hrs after dosing. What was key is they did not see meaningful changes in the QT. There was no clinical or meaningful changes in QT, no pro-arrhythmic events, or no cardiovascular SAE’s observed with Zenvia in the STAR Trial. From an efficacy perspective from 30/30 to 30/10 there was no loss. By reducing the amount of quinidine from 30mg to 10mg the FDA believed they would see an improvement in safety.

    Falls was also an area of concern for the FDA with respects to Zenvia. The FDA was concerned that patients with M.S. and ALS are already unstable as a result of their underlying diseases. They wanted to be confident that the addition of Zenvia did not lead to incremental falls for those patients. Across the study there was no difference in falls in these patient populations. There was also no difference in falls separately from underlying M.S. or ALS. There were also concerns of nausea, somnolence, and dizziness in the study but many of these symptoms went away as patients were in the study. Nausea went down dramatically & dizziness went down with the 30/10 formulation and 20/10 had a 10% incidence which is much lower than initially observed. Fatigue was also down dramatically. This resulted in a much lower discontinuation rate. What is very key to note is that on a 30/10 dose formulation that over 90% of the patients completed the study. That is a significant accomplishment given the large population in the study.


    SortNewest  |  Oldest  |  Most Replied Expand all replies