Anavex Life Sciences Corp (AVXL)

[Doc328]

Actually, by the end of part A (5 weeks), 30/32 patients had at least one AE, close to 98%. Would not be surprising if one of the other two had a mild AE by 31 weeks. Most were grade 1 or 2 and the most common were dizziness and headache. AE's more commonly occurred during the first week or two. To me the side effect profile looks similar to most CNS drugs on the market, but not necessarily better. Comparing AE's is difficult without placebo. Of the 32 patients who enrolled, there were 5 serious AE's by 31 weeks, including one cancer (probably not related).

If marketed, the prescribing info will have to list all the AE's, regardless of severity, that occurred in studies at a rate of more than 2% and any serious AE. So the list will be long and look similar to other drugs. This needs to be kept in mind when comparing topline data to FDA/EMA/TGA prescribing info for other drugs.

5 week data

31 week data