Qudexy XR is indicated as initial monotherapy in patients ten years of age and older with POS or primary generalized tonic-clonic seizures.
The once-daily, broad-spectrum antiepileptic drug is specifically engineered to deliver a smooth pharmacokinetic (PK) profile.
Qudexy XR is also approved as adjunctive therapy in patients two years of age and older with POS, primary generalized tonic-clonic seizures and seizures related with Lennox-Gastaut syndrome.
The company said that Qudexy XR allows patients to sprinkle capsule contents on soft food if they experience any challenges swallowing whole capsules or tablets.
The drug will be available in 25mg, 50mg, 100mg, 10mg, and 200mg extended-release capsules and it will be marketed to patients in the second quarter of 2014.
The FDA approval is based on results from the randomized, multicenter, double-blind, placebo-controlled, parallel-group Phase III PREVAIL trial, where Qudexy XR showed efficacy and tolerability in epilepsy patients with refractory POS.
The trial, which enrolled 249 adult patients worldwide at 66 centers, showed that the drug met its endpoints for efficacy.
Upsher-Smith president and CEO Mark Evenstad said the FDA approval is a major milestone in the company’s history, as Qudexy XR is the first branded product in its central nervous system portfolio.
"At Upsher-Smith, our mission is to make a measurable improvement in people’s lives by focusing on the patient," Evenstad said.