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FDA Approves Extended-Release Topiramate (Qudexy XR) for Seizures

Launch expected in second quarter of 2014

The FDA has approved topiramate extended-release capsules (Qudexy XR, Upsher-Smith Laboratories), a once-daily, broad-spectrum anti-epileptic drug.

The medication is indicated as initial monotherapy in patients 10 years of age and older with partial-onset seizures (POS) or primary generalized tonic-clonic seizures. It is also approved as adjunctive therapy in patients 2 years of age and older with POS, with primary generalized tonic-clonic seizures, or with seizures associated with Lennox-Gastaut syndrome. The medication will be available in the second quarter of 2014.

As many as two out of three patients treated for epilepsy have seizures that are refractory to therapy, either because they have incomplete control of their seizures or they experience treatment-related side effects that interfere with their quality of life.

Results from the global phase III PREVAIL trial of extended-release topiramate demonstrated that the drug is effective and generally well-tolerated. All medication strengths — 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg — may be swallowed whole or administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of soft food. This makes Qudexy XR the only approved extended-release topiramate product for patients who experience challenges swallowing whole capsules or tablets.

The PREVAIL trial was a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of extended-release topiramate as adjunctive therapy in patients with refractory POS. The study enrolled 249 adult patients worldwide.

Results from the PREVAIL study showed that the drug met its endpoints for efficacy and demonstrated favorable safety and tolerability in epilepsy patients with refractory POS. The findings demonstrated that extended-release topiramate was associated with a significantly greater median percent reduction from baseline in the frequency of POS compared with placebo (39.5% vs. 21.7%, respectively; P

It has been estimated that more than 2 million people in the U.S. have epilepsy, with about 200,000 new cases diagnosed each year.

Source: Upsher-Smith Laboratories; March 12, 2014.

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