Replies to post #437473 on Anavex Life Sciences Corp (AVXL)

[georgejjl]

Yes, there was a problem with the up titration plan.

They forgot to include a 40 mg per day dose between the 30 mg per day and the 50 mg per day doses.

The dose titration was as follows 10 mg per day for 4 days, followed by 20 mg per day for 4 days followed by 30 mg per day for 4 days followed by if the target dose included a 50 mg/day dose. Down titration to the previously tolerable dose would occur at any dose that is not tolerable.

Also, in addition to not including a 40 mg/day dose the period between doses should have been 2 weeks for each transient incremental titration dose.

The dose titration should have been as follows 10 mg per day for 14 days, followed by 20 mg per day for 14 days, followed by 30 mg per day for 14 days, and for a target dose cohort of 50 mg/day add a 40 mg per day for 14 days, followed by if the target dose included a 50 mg/day. Down titration to the previously tolerable dose would occur at any dose that is not tolerable.

GOD bless,

[georgejjl]

When initiating a new ASM, a "start low, go slow" titration approach is generally recommended and has been shown to reduce the risk of severe idiosyncratic reactions with certain medications and improve tolerability with regard to many frequently occurring central nervous system-related adverse effects

https://www.epilepsybehavior.com/article/S1525-5050(21)00778-2/fulltext

Good luck and GOD bless,