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.
you being ignored on this board is nothing unusual, actually there are several jerks here. Ya ask a simple question and they spout off some nonsense and tell you to read through some hemhaw or listen to this or that when they could easily answer it but just being jerks
After seeing ARNA get shot down today I have doubts about AVNR. Looking relatively safe doesn't seem good enough for the FDA. I think they are getting overly cautious. There is enough saftey concerns, small as they maybe, that I am just not sure how the FDA will vote. I put it at 50/50. The people on the ARNA board was so sure it would pass but surprise you can never guess the FDA.
Not sure I will hold all or sell half before Oct 30. The risk/reward is still good in that I think it will easily double if approved but go down 40 to 50 percent if not.
ARNA's diet pill, for starters .... 1)worked only "by a slim marign".... 2)had three noteworthy safety issues - heart-valve disease, physciatric and memory problems and cancerous tumors. See the news release. It's no wonder there are serious doubts about its approval.
Zenvia (or whatever new name will be) has none issues even close to the problems set forth in ARNA's new release; further, Zenvia "works" by great margins as show by 400 patient years data.
Best of luck with your choice. Each to their own.
Good luck longs, Mr. T