Clinical efficacy
Primary Efficacy End Point1: Mean change in total YMRS score from baseline to Day 21 (mITT population, N = 228)
| Change from Baseline to Day 21 | ZONALTA (N=116) | Divalproex (N=112) | Point Estimate | 95% Confidence Interval |
|---|---|---|---|---|
| Least Square Mean | ||||
| 15.59 | 15.76 | -0.17 | -2.50 – 2.16 | |
As lower limit of 95% confidence interval for change in the total YMRS score from baseline to EOT (End of treatment) was greater than -10, ZONALTA can be considered non-inferior to the divalproex.
In Phase III clinical trial,
ZONALTA demonstrated a significant reduction in the mean YMRS score similar to divalproex
Mean total YMRS score at each visit. T = ZONALTA 8 mg/day;
R = divalproex 1,000 mg/day.
ZONALTA was approved based on the primary endpoint, mean change in YMRS total score from baseline to Day 21.
Study design1: A double-blind, double-dummy, active-controlled, oral, multiple-dose, parallel, randomized study to evaluate efficacy and safety of ZONALTA in bipolar I disorder patients. Patients were treated with either ZONALTA 8 mg (n=116) or divalproex extended-release tablets 1000 mg (n=112). Mean change in YMRS score from baseline to end of Day 21 was analyzed.
References
- 1. Ahmad A, Sheikh S, Khan MA, Chaturvedi A, Patel P, Patel R, et al. Endoxifen: A New, Protein Kinase C inhibitor to treat acute and mixed mania associated with bipolar I disorder. Bipolar Disord. 2020 Dec 25. doi: 10.1111/bdi.13041. Epub ahead of print.