Upsher-Smith Laboratories has received FDA approval for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic (PK) profile.  Qudexy XR 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 also is approved as adjunctive therapy in patients two years of age and older with POS, primary generalized tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome. Qudexy XR will be available to patients 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 Upsher-Smith’s phase III trial (PREVAIL) of Qudexy XR demonstrated that the drug is effective and generally well-tolerated.  Additionally, Qudexy XR offers patients flexibility.  All strengths of Qudexy XR may be swallowed whole or administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of soft food.  This makes it the only approved extended-release topiramate product for patients who experience challenges swallowing whole capsules or tablets.

Mark Evenstad, president and CEO of Upsher-Smith, said, “Today’s approval is a major milestone in Upsher-Smith’s history, as Qudexy XR is the first branded product in our central nervous system portfolio.”

Qudexy XR is available in 25mg, 50mg, 100mg, 150mg and 200mg extended-release capsules. The global phase III (PREVAIL) trial was a randomized, multicenter, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of Qudexy XR as adjunctive therapy in patients with refractory POS.  The study enrolled 249 adult patients worldwide at 66 centers. 

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 Qudexy XR was associated with a significantly greater median percent reduction from baseline in POS frequency compared with placebo (39.5% v. 21.7%, P