Upsher-Smith Laboratories (Upsher-Smith) has secured approval from the US Food and Drug Administration (FDA) for Qudexy XR (topiramate) extended-release capsules, indicated as initial monotherapy in patients ten years or older with partial-onset seizures (POS) or primary generalised tonic-clonic seizures.
Approval is based on results from the randomised, multicentre, double-blind, placebo-controlled, parallel-group Phase III PREVAIL trial, where Qudexy XR showed efficacy and tolerability in epilepsy patients with refractory POS.
A total of 249 adult patients worldwide were enrolled in the trial, which was carried out at 66 centres. Its results showed that the drug met its endpoints for efficacy.
A significantly greater median percent reduction from baseline in partial-onset seizure frequency was observed in the Qudexy XR treatment group vs. placebo (39.5% vs. 21.7%; P<0.001) after 11 weeks of treatment.
The once-daily, broad-spectrum antiepileptic drug Qudexy XR is specifically engineered to deliver a smooth pharmacokinetic (PK) profile.
It is also approved as adjunctive therapy in patients aged two years and older with POS, primary generalised tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome.
According to the company, Qudexy XR allows patients to sprinkle capsule contents on soft food if they experience any challenges swallowing whole capsules or tablets.
Upsher-Smith president and chief executive officer 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.
Qudexy XR will be available in 25mg, 50mg, 100mg, 10mg, and 200mg extended-release capsules. It will be marketed to patients in the second quarter of 2014.
The Barrow Neurological Institute in Phoenix professor of Neurology and trial investigator Steve Chung said: "PREVAIL demonstrated that Qudexy XR was efficacious and generally well-tolerated, particularly with respect to the incidence of cognitive side effects."
In addition to Qudexy XR, Upsher-Smith’s clinical development pipeline includes two investigational drugs, USL261 and USL260 (tonabersat), which are being studied for the management of seizure disorders.
USL261 is an investigational intranasal midazolam for the rescue treatment of seizures in patients requiring control of intermittent bouts of increased seizure activity, while USL260 is in early clinical development as a potential first-in-class neuronal gap junction modulator.