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

RATIONALE:

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.

METHODS:

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.

RESULTS:

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.

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