Anavex Life Sciences Corp (AVXL)

[F1ash]

F1ash, if the participants were always dizzy and/or had other adverse effects, do you think they and the caretakers would have asked for a TWO YEAR EXTENSION?

Probably not. I get the distinct feeling that you believe I am slamming A2-73 because it has side effects. That's not the case at all.

Here was the opening question:

I don't think with current trial anyone will go over..
but for a healthy population 60mg is probably still well tolerated..

I replied with quotes from the Phase 1 trial (with health adults.)

In summary, there was a clear trend for dose dependence of both frequency and intensity of TEAEs across the AV2-73 dose levels from 1 to 60 mg. Three out of four subjects at 60 mg experienced in total 6 dose limiting TEAEs.

The remaining 9 TEAEs had moderate intensity and exclusively occurred at the highest dose levels 55 and 60 mg.
The number of affected subjects increased with increasing dose from 2 of 6 (25%) subjects to 4 of 4 subjects (100%) at the 30 mg and 60 mg dose steps, respectively.

Gastrointestinal effects were predominantly observed at the highest 60 mg dose. The complaints were abdominal pain (1), nausea (2), vomiting (3), and acute diarrhea (1). Other side effects observed were one subject experienced euphoric mood and one subject presented with mild depressive symptoms, each at the highest dose levels.
In summary, there was a clear trend for dose dependence of both frequency and intensity of TEAEs across the AV2-73 dose levels from 1 to 60 mg. Three out of four subjects at 60 mg experienced in total 6 dose limiting TEAEs.

Pharmacokinetics: ANAVEX2-73: The mean of maximum plasma concentration (C values of AV2-73 showed a dose dependent increase with exception of the 60 mg dose step.


http://www.anavex.com/my_uploads/2014-11-14_Poster_Anavex_2-73_Phase_1_Study_CNS_Summit_2014.pdf

Note that I edited the quotes this time in an effort to just answer the initial question better.


"Treatment emergent adverse events (TEAE) are undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment. ... A treatment emergent adverse event (TEAE) is an adverse event that occurs only once treatment has started.Oct 29, 2015"

https://www.google.com/search?q=teae%20definition&ie=utf-8&oe=utf-8