Supernus Provides Update on SPN-810 Phase III Clinical Trials
September 18 2017 - 4:04PM
Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a specialty
pharmaceutical company focused on developing and commercializing
products for the treatment of central nervous system (CNS)
diseases, today announced the outcome of the planned interim
analysis from the first Phase III clinical trial on SPN-810.
The Company is developing SPN-810 as a novel treatment for
impulsive aggression (IA) in patients aged 6 to 12 years who have
attention deficit hyperactivity disorder (ADHD). SPN-810 is being
tested in two Phase III clinical trials at total daily doses of 18
mg and 36 mg against placebo. The two trials are being conducted
using an agreed-upon novel scale to measure IA that was developed
by the Company with the FDA under a Special Protocol Assessment
(SPA). The two trials are of the same design except that under the
SPA, an interim analysis was planned in the first trial when
one-half of the patients (146 patients) reached randomization.
The purpose of the interim analysis is to assess the doses being
tested and allow for optimization of the trial design of both
trials. The interim analysis was conducted by an independent third
party statistician with clear and strict guidelines that do not
compromise the quality or blinding of the trials and that were
predefined under the SPA prior to the initiation of the trials. The
benefit of structuring the first trial with an interim analysis is
to enable the Company to implement certain actions that would
maximize the probability of success. These actions include, but are
not limited to: terminating the trials due to an expectation of
futility; dropping one of the dose arms; increasing the number of
patients to be recruited; or simply continuing the trials
unchanged.
The interim analysis has been completed and both trials will
continue through to completion. Based on the predefined
criteria for dropping a dose arm, the lower dose of 18 mg will be
eliminated. Moving forward, all patients will be randomized to
either the 36 mg dose arm or placebo until the predetermined total
number of patients are enrolled without changing the size of the
trials. The Company believes that this will maximize the
probability of reaching a statistically significant outcome for the
36 mg dose. Implementation of these changes will start immediately.
We continue to expect enrollment through mid-2018.
Current enrollment is at approximately 64% for the first trial
and 56% for the second trial. Enrollment in the open label
extension study continues to be very encouraging at a high level of
90%.
"We are pleased to have included an interim analysis in the
design of the first trial that allows us to implement predefined
measures to optimize the trials and better position them for
success. We are committed to bringing this novel treatment to
patients who currently have no proven and approved options," said
Jack Khattar, President & CEO of Supernus
Pharmaceuticals.
Conference Call Details
The Company will hold a conference call hosted by Jack Khattar,
President and Chief Executive Officer, and Stefan Schwabe,
Executive Vice President and Chief Medical Officer at 5:00 p.m. ET,
on Monday, September 18, 2017. An accompanying webcast also will be
provided.
Please refer to the information below for conference call
dial-in information and webcast registration. Callers should dial
in approximately 10 minutes prior to the start of the call.
Conference dial-in: (877) 288-1043
International dial-in: (970) 315-0267
Conference ID: 88391639
Conference Call Name: Supernus Pharmaceuticals SPN-810
Conference
Call
Following the live call, a replay will be available on the
Company's website, www.supernus.com, under ‘Investors’.
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical
company focused on developing and commercializing products for the
treatment of central nervous system 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 psychiatry, including SPN-810
for the treatment of IA in ADHD patients and SPN-812 for the
treatment of ADHD.
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 successfully complete the development of its product
candidates including SPN-810; 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; 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 SEC
filings 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, Vice
President and CFOSupernus Pharmaceuticals, Inc.Tel: (301)
838-2591
or
INVESTOR CONTACT:Peter VozzoWestwicke PartnersOffice: (443)
213-0505Mobile: (443) 377-4767Email: peter.vozzo@westwicke.com
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