Supernus Announces Release of Exciting New Clinical Data on Trokendi XR(TM)
ROCKVILLE, Md., Nov. 6, 2013 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals,
Inc. (Nasdaq:SUPN), a specialty pharmaceutical company, today announced that
new clinical data will be released at the American Epilepsy Society (AES)
Meeting this coming December in Washington DC.
The first abstract titled "Cognitive Effects of Extended-Release, Once-Daily
Trokendi XR™ vs b.i.d. Immediate-Release Topiramate (TPM-IR, Topamax^®) in
Healthy Volunteers" will be presented at the meeting on December 7, 2013
followed by several other abstracts.
COGNITIVE EFFECTS OF EXTENDED-RELEASE, ONCE-DAILY TROKENDI XR™ VS B.I.D.
IMMEDIATE-RELEASE TOPIRAMATE (TPM-IR, TOPAMAX^®) IN HEALTHY VOLUNTEERS
Authors: S. Schwabe, S. Brittain
Dose-management strategies (slow titration, low doses) improve the
tolerability of TPM, a potent, broad-spectrum AED that can cause distinctive
cognitive symptoms (e.g., word-finding difficulty). Neuropsychometric tests
have shown significant negative changes, especially in verbal fluency, in a
relatively small subset of patients receiving TPM-IR. SPN-538 (Trokendi XR,
Supernus Pharmaceuticals, Inc.) is a novel extended-release, once-daily
capsule formulation of TPM that may improve tolerability and adherence. In a
crossover study in healthy volunteers establishing bioequivalence of
once-daily SPN-538 to b.i.d. TPM-IR (200 mg/day), effects of treatments on
cognitive function were compared.
Design: Single-blind, randomized-sequence, crossover study in healthy adults.
Treatments: b.i.d. TPM-IR and once-daily SPN-538 (AM, active drug; PM,
matching placebo) force-titrated in 50-mg weekly increments over 4 wks to 200
mg/day for 10 days; 32-day washout between periods. Cognitive tests (verbal
fluency: Controlled Oral Word Association, COWA; processing speed: Digit
Symbol Substitution Test, DSST) performed before the AM dose on Days 1
(baseline); 8 (50 mg/day), 15 (100 mg/day), 22 (150 mg/day), 31 (200 mg/day),
and 38 (washout). Between-treatment comparisons were evaluated by fitting a
repeated measures linear mixed model with fixed effects for treatment,
sequence, period, day, and treatment by day.
In the per-protocol analysis of all subjects with data (TPM-IR, n=39; SPN-538,
n=34), COWA change scores favored once-daily SPN-538 over b.i.d. TPM-IR at all
test points; differences were significant at 50 (P=0.05) and 100 mg/day
(P=0.0002) and for the entire treatment period (P=0.005). Subjects with
moderate/severe ( > 1 SD) negative COWA changes: TPM-IR, 42%; SPN-538, 12%).
Similar patterns for DSST changes did not reach statistical significance.
Based on the per-protocol analysis of COWA change scores, the
concentration-time profile of once-daily SPN-538 was associated with
significantly less negative impact on COWA despite PK bioequivalence to b.i.d.
TPM-IR on all standard PK parameters, similar C[avg0-24] (SPN-538, 6.1 µg/mL;
TPM-IR, 6.3 µg/mL), and nearly identical mean TPM concentrations (5.6 µg/mL)
when cognitive function tests were performed 18 (SPN-538) and 10 (TPM-IR) hrs
after T[max]. Once-daily SPN-538 produces more consistent TPM plasma
concentrations (14% difference, P < 0.001, in peak-trough fluctuation) due to
a markedly slower absorption rate (24-fold difference vs TPM-IR). COWA, known
to be highly sensitive to specific effects of TPM, may be sensitive to
differences in rates at which TPM concentrations increase/change. Further work
to confirm these findings as well as elucidate their potential clinical
significance is warranted. Funded by Supernus Pharmaceuticals, Inc.
All abstracts are now available on the AES website, www.aesnet.org by
conducting an "Abstract Search" for "Trokendi XR".
· Cognitive Effects of Extended-Release, Once-Daily Trokendi XR™ vs b.i.d.
Immediate-Release Topiramate (TPM-IR, Topamax^®) in Healthy Volunteers
·Linearity and Dose Strength Equivalence of Once-Daily, Extended-Release
Topiramate (Trokendi XR™, SPN-538)
·Steady-State Bioequivalence of Extended-Release, Once-Daily Trokendi XR™
(SPN-538) to Immediate-Release Topiramate (TPM-IR, Topamax^®)
·Pharmacokinetic Rationale for mg-for-mg Overnight Switch from Twice-Daily
Immediate-Release Topiramate (TPM-IR) to Once-Daily, Extended-Release Trokendi
·Once-Daily Trokendi XR™ (SPN-538) vs. Twice-Daily Topamax^®: Impact of
Nonadherence on Topiramate Concentrations
·Pharmacokinetics of Once-Daily, Extended-Release Trokendi XR™ (SPN-538) in
"We are looking forward to presenting these exciting new data on Trokendi XR
at the AES meeting. The product was launched in August of this year and is off
to a solid start since its launch with positive feedback from the market
confirming its unique benefits to epilepsy patients," said Jack Khattar,
President & CEO, of Supernus.
About Trokendi XR™
Trokendi XR is the only approved once-daily extended release formulation of
topiramate for the treatment of epilepsy. Trokendi XR is an antiepileptic drug
indicated for initial monotherapy in patients 10 years of age and older with
partial onset or primary generalized tonic-clonic seizures; adjunctive therapy
in patients 6 years of age and older with partial onset or primary generalized
tonic-clonic seizures; and adjunctive therapy in patients 6 years of age and
older with seizures associated with Lennox-Gastaut syndrome. The product is
available in 25mg, 50mg, 100mg and 200mg extended-release capsules.
For full prescribing and safety information, click here.
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, or CNS, diseases. The Company has two marketed products for
epilepsy, Oxtellar XR™ (extended-release oxcarbazepine) and Trokendi XR™
(extended-release topiramate). The Company is also developing several product
candidates in psychiatry to address large market opportunities in ADHD,
including ADHD patients with impulsive aggression. These product candidates
include SPN-810 for impulsive aggression in ADHD and SPN-812 for ADHD.
This press release contains forward-looking statements regarding clinical data
and the potential for Trokendi XR to treat epilepsy. Actual results may differ
materially from those in these forward-looking statements as a result of
various factors, including, but not limited to, risks regarding the company's
ability to commercialize the product successfully, whether physicians will
prescribe and patients will use the product, and competition in the market.
For a further description of these and other risks facing the Company, please
see the risk factors described in the Company's Annual Report Form 10-K that
was filed with the United States Securities and Exchange Commission on March
15, 2013 and under the caption "Risk Factors" and the updates to these risk
factors in the Company's quarterly report form 10-Q that was filed with the
Commission on August 15, 2013. Forward-looking statements speak only as of the
date of this press release, and the company undertakes no obligation to update
or revise these statements, except as may be required by law.
CONTACT: Jack A. Khattar, President and CEO
Gregory S. Patrick, Vice President and CFO
Supernus Pharmaceuticals, Inc.
Tel: (301) 838-2591
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