Upsher-Smith launches Qudexy XR capsules to treat specific seizure types

Qudexy XR is a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic (PK) profile. It was approved by the U.S. Food and Drug Administration in March 2014 as initial monotherapy in patients 10 years of age and older with partial-onset seizures (POS) or primary generalized tonic-clonic seizures.

It was also 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. The capsule contents of all strengths may be sprinkled onto a spoonful of soft food.

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.

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

"The launch of our first branded product within our central nervous system portfolio marks a significant milestone in Upsher-Smith’s history and demonstrates our focus ondeveloping medications that can make a meaningful difference in people’s lives," said Bill Pullman, MB, BS, Phd, FRACP, and Chief Scientific Officer of Upsher-Smith.

"We are pleased to bring this product forward to treat specific seizure disorders and offer another treatment option to the epilepsy community."