Supernus Provides Update on Results from Phase III Study (P301) of SPN-810 for Treatment of Impulsive Aggression (IA) in ADHD Patients
In early
After conducting further analysis on the P301 data, the Company believes that the high variability in the 36mg treatment arm was primarily due to 6 patients out of 135 that had a mild IA condition with a baseline score of 6 episodes or less per week. In the placebo arm, there were 7 patients with the same mild IA condition. By excluding these subjects from the placebo and the 36mg treatment arm, the primary analysis (combined stage 1 and 2 data) of the P301 data on the primary endpoint results in a p value of 0.017 for the treatment arm compared to placebo. This positive result is also confirmed by the sensitivity analysis on the primary endpoint with a p value of 0.044.
Percent Change from Baseline (CFB) in the Frequency of IA Behaviors
Treatment Period - Primary Analysis (ITT Population)
Original Analysis |
Analysis Excluding Patients with Baseline Score of 6 or less Episodes per Week | |||
Stage 1 - % CFB | Placebo | SPN-810 36mg |
Placebo | SPN-810 36mg |
N | 52 | 45 | 50 | 44 |
Mean (SD) | -42.9 (35.9) | -56.6 (34.1) | -44.8 (29.9) | -55.6 (33.8) |
Median | -48.6 | -60.0 | -48.6 | -57.8 |
P-value | 0.029 | 0.039 | ||
Stage 2 - % CFB | ||||
N | 73 | 90 | 68 | 85 |
Mean (SD) | -43.8 (36.3) | -44.0 (43.5) | -42.0 (35.3) | -49.1 (36.6) |
Median | -47.2 | -58.5 | -46.2 | -59.2 |
P-value | 0.5370 | 0.119 | ||
Stages 1 & 2 Combined - % CFB | ||||
N | 125 | 135 | 118 | 129 |
Mean (SD) | -43.4 (36.0) | -48.2 (40.9) | -43.2 (33.0) | -51.3 (35.7) |
Median | -48.2 | -58.6 | -47.2 | -59.2 |
P-value | 0.092 | 0.017 |
The Company plans on finalizing the statistical plan (SAP) for the second Phase III P302 study in patients 6 to 11 years old taking into consideration the exclusion of patients with 6 or less episodes of IA per week. The Company will be submitting the SAP to the
The P503 adolescent Phase III study in patients 12 to 17 years old had been designed from the outset with an exclusion criterion that excludes patients with a baseline score of 6 or less episodes per week.
“Based on this new analysis, we are hopeful that the second Phase III study will be positive, and if so, that future discussions with the
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Source: Supernus Pharmaceuticals, Inc.