Quote:
Below are the concerns from the Approvable Letter and the answers to them from the STAR trial in the Special Protocol Assessment (SPA).
1) Concern: -Potential for QT interval prolongation
Answer: -New low dose formulations reduced quinidine exposure by 67%, reduced QTc outliers & should increase margin of cardiac safety
- No clinically meaningful changes in QTc, no pro-arrhythmic and no cardiovascular SAEs were seen in STAR trial
2) Concern: -Rate of AEs in “vulnerable” ALS population
Answer: Substantial reduction in rates of common AEs (nausea, dizziness, fatigue, etc.) compared to what was reported previously
3) Concern: -Potential for increased risk of falls
Answer: No difference b/w Zenvia 30/10 mg and placebo reported Incidence of falls
4) Concern: -Potential for respiratory depression in ALS
Answer: -No acute de-compensation of respiratory function observed after initiation of study drug
-Full analysis of nocturnal O2 saturation showed no difference versus placebo
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If you've been watching the development of this drug (ZenviaŽ) it's interesting that potential for intoxication or abuse hasn't been raised as a possible concern yet.