Upsher-Smith announces FDA approval of sNDA for Qudexy XR extended-release capsules

Jun 2 2015

Upsher-Smith Laboratories, Inc. (Upsher-Smith) announced that it has received U.S. Food and Drug Administration (FDA) approval of a supplemental new drug application (sNDA) for Qudexy^® XR (topiramate) extended-release capsules for use as initial monotherapy in patients two years of age and older who are experiencing partial-onset seizures (POS) or primary generalized tonic-clonic seizures.

Qudexy^® XR capsules are the only once-daily extended-release topiramate product to have received this expanded indication and to be approved for administration by sprinkling their contents onto soft food, making them a useful option for young children who may have difficulty swallowing whole capsules or tablets. Qudexy^® XR is a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.

"The expanded indication gives physicians the option to prescribe Qudexy^® XR as initial monotherapy in patients as young as two years old," said William Pullman, MB BS, BMedSc, PhD, FRACP, Chief Scientific Officer, Upsher-Smith. "This, combined with its ability to be sprinkled on soft food for ease of administration, makes it a viable treatment option for the pediatric patient population."

Qudexy^® XR was previously approved for use as initial monotherapy in patients 10 years of age and older with POS or primary generalized tonic-clonic seizures. Qudexy^® XR is also approved as an adjunctive therapy in patients two years of age or older with POS, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. Qudexy^® XR has been available in the United States since June 2014.