Upsher-Smith Receives FDA Approval for Qudexy

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Upsher-Smith Receives FDA Approval for Qudexy™ XR (Topiramate) Extended-Release Capsules

March 12, 2014

Upsher-Smith Laboratories, Inc., announced it received approval on March 11, 2014 from the U.S. Food and Drug Administration (FDA) 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 is also approved as adjunctive therapy in patients 2 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.1  Results from Upsher-Smith’s Phase 3 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.

“Upsher-Smith is pleased by the FDA’s approval of Qudexy™ XR,” said Mark Evenstad, President and Chief Executive Officer of Upsher-Smith.  “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.  At Upsher-Smith, our mission is to make a measurable improvement in people’s lives by focusing on the patient.”

“PREVAIL demonstrated that Qudexy™ XR was efficacious and generally well-tolerated, particularly with respect to the incidence of cognitive side effects,” said Steve Chung, M.D., Professor of Neurology at the Barrow Neurological Institute in Phoenix and trial investigator.  “As a physician, I’m encouraged that Qudexy™ XR will be an available treatment option for many patients.”

Qudexy™ XR is available in 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg extended-release capsules.

About Upsher-Smith’s Phase 3 (PREVAIL) Clinical Trial

The global Phase 3 (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% vs 21.7%, P<0.001) after 11 weeks of treatment.

INDICATIONS

Qudexy™ XR (topiramate) extended-release capsules is a prescription medicine used:

  • to treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 10 years of age and older,
  • with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older.

Read more here.

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