Supernus Provides Update on Results from Phase III Study (P301) of SPN-810 for Treatment of Impulsive Aggression (IA) in ADHD Patients
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)
||Analysis Excluding Patients with Baseline Score of 6 or less Episodes per Week|
|Stage 1 - % CFB||Placebo||SPN-810
|Mean (SD)||-42.9 (35.9)||-56.6 (34.1)||-44.8 (29.9)||-55.6 (33.8)|
|Stage 2 - % CFB|
|Mean (SD)||-43.8 (36.3)||-44.0 (43.5)||-42.0 (35.3)||-49.1 (36.6)|
|Stages 1 & 2 Combined - % CFB|
|Mean (SD)||-43.4 (36.0)||-48.2 (40.9)||-43.2 (33.0)||-51.3 (35.7)|
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
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information, but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products; the Company’s ability to increase its net revenue; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates including SPN-810; the Company’s ability to protect its intellectual property and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; and other risk factors set forth from time to time in the Company’s filings with the
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Source: Supernus Pharmaceuticals, Inc.