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Upsher-Smith Presents New Data On The PK Equivalence Of USL255 (Extended-Release Topiramate) When Sprinkled On Food Or Swallowed Intact
Date:12/10/2013

MAPLE GROVE, Minn., Dec. 10, 2013 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. (Upsher-Smith), today announced the presentation of new Phase 1 data showing that USL255 (extended-release topiramate) may provide a beneficial treatment option for individuals with difficulty swallowing whole capsules or tablets.  Additionally, simulations of data from another Phase 1 study demonstrated a return to steady-state topiramate levels within one 24-hour dosing interval, suggesting, for USL255 doses delayed up to 18 hours, the risk of dropping to sub-therapeutic concentrations is minimized.  The data were presented for the first time at the American Epilepsy Society's (AES) 67th Annual Meeting in Washington, DC, December 6-10, 2013. 

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Upsher-Smith presented two abstracts with Phase 1 data on USL255, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic (PK) profile.  It is being developed by Upsher-Smith for the treatment of seizure disorders. Upsher-Smith's New Drug Application for USL255 has been accepted for review by the U.S. Food and Drug Administration (FDA). When approved, USL255 may offer dosing flexibility because it can be swallowed whole or the capsule contents of all strengths may be sprinkled onto soft food.

Phase 1 data presented at AES came from a single-dose study (N=36) that evaluated the PK profile of 200 mg of USL255 administered to healthy volunteers. Subjects were randomized to receive both an intact USL255 200 mg capsule taken under fasting conditions and three weeks later a 200 mg capsule of USL255 opened and sprinkled onto one tablespoonful of applesauce after an overnight fast.
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