Supernus Provides Update on Results from Phase III Study (P301) of SPN-810 for Treatment of Impulsive Aggression (IA) in ADHD...
December 09 2019 - 4:15PM
Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical
company focused on developing and commercializing products for the
treatment of central nervous system (CNS) diseases, is providing an
update on the results from the first Phase III study (P301) of
SPN-810, a novel treatment of Impulsive Aggression (IA) in patients
with ADHD.
In early November 2019, the Company reported topline results
from the Phase III P301 trial in patients 6 to 11 years. The study
was a randomized, double-blind, placebo controlled, multicenter,
parallel group clinical trial in patients diagnosed with ADHD.
Patients receiving SPN-810 36mg showed a median percent reduction
of 58.6% in the average weekly frequency of impulsive aggression
episodes from baseline that was not statistically significant
(p=0.092) compared to placebo. These results are based on the
combined analysis of data from stages 1 and 2 in the study. In
stage 1 (interim analysis stage), the median percent reduction was
60.0%, which was statistically significant (p=0.029) compared to
placebo. However, in stage 2 of the P301 study, post the interim
analysis, the increase in variability in the 36mg treatment arm
seems to have adversely impacted the results in the combined
analysis.
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 BehaviorsTreatment 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-81036mg |
Placebo |
SPN-81036mg |
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 Food and Drug Administration (FDA) and expects data from the
P302 study in the first quarter of 2020.
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 FDA will be productive in progressing this
potential novel treatment,” said Jack Khattar, President and CEO of
Supernus. “While there are no assurances that SPN-810 will
eventually progress forward and obtain FDA approval, we continue to
believe that with a clinically meaningful reduction of
approximately 60% in IA episodes, it can be a real treatment option
for patients who currently have no proven products to help them
manage their condition,” added Mr. Khattar.
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals, Inc. is a pharmaceutical company
focused on developing and commercializing products for the
treatment of central nervous system (CNS) diseases. The Company
currently markets Trokendi XR® (extended-release topiramate) for
the prophylaxis of migraine and the treatment of epilepsy, and
Oxtellar XR® (extended-release oxcarbazepine) for the treatment of
epilepsy. The Company is also developing several product candidates
to address large market opportunities in the CNS market, including
SPN-812 for the treatment of ADHD and SPN-604 for the treatment of
bipolar disorder.
Forward-Looking Statements:
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 Securities and Exchange Commission made pursuant to
Section 13 or 15(d) of the Securities Exchange Act of 1934, as
amended. The Company undertakes no obligation to update the
information in this press release to reflect events or
circumstances after the date hereof or to reflect the occurrence of
anticipated or unanticipated events.
CONTACTS:
Jack A. Khattar, President and CEOGregory S. Patrick, Senior
Vice President and CFOSupernus Pharmaceuticals, Inc.Tel: (301)
838-2591
or
INVESTOR CONTACT:Peter VozzoWestwicke, an ICR CompanyOffice:
(443) 213-0505Mobile: (443) 377-4767Email:
peter.vozzo@westwicke.com
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