The first abstract titled "Cognitive Effects of Extended-Release, Once-Daily Trokendi XR™ vs b.i.d. Immediate-Release Topiramate (TPM-IR, Topamax®) in
COGNITIVE EFFECTS OF EXTENDED-RELEASE, ONCE-DAILY TROKENDI XR™ VS B.I.D. IMMEDIATE-RELEASE TOPIRAMATE (TPM-IR, TOPAMAX®) IN HEALTHY VOLUNTEERS
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,
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:
In the per-protocol analysis of all subjects with data (TPM-IR, n=39; SPN-538, n=34),
Based on the per-protocol analysis of
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
· Linearity and Dose Strength Equivalence of
· 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 Trokendi XR™ (SPN-538) vs. Twice-Daily Topamax®: Impact of Nonadherence on Topiramate Concentrations
· Pharmacokinetics of
"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
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.
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
Jack A. Khattar, President and CEO Gregory S. Patrick, Vice President and CFO Supernus Pharmaceuticals, Inc.Tel: (301) 838-2591
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