FDA approves once-daily topiramate XR for refractory seizures

March 18, 2014

FDA has approved once-daily topiramate extended-release capsules for initial monotherapy to treat partial-onset or primary generalized tonic-clonic seizures.

FDA approved once-daily topiramate (Qudexy XR,Upsher-Smith Laboratories) extended-release capsules for initial monotherapy in patients aged 10 years and older with partial-onset seizures (POS) or primary generalized tonic-clonic seizures. 

It is 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. 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, according to Epilepsy.com.

Results from the phase 3 multicenter trial (PREVAIL) evaluated 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. The PREVAIL study showed that the drug met its end points 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<.001) after 11 weeks of treatment.

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 is important for patients who experience challenges swallowing whole capsules or tablets.

According to the Epilepsy Foundation, epilepsy is a medical condition that is characterized by recurrent seizures. More than 2 million people in the United States are estimated to be affected by epilepsy with about 200,000 new cases of epilepsy diagnosed each year. Epilepsy can be associated with profound physical, psychological, and social consequences that negatively impact people’s lives.

 

 

Qudexy XR is available in 25-mg, 50-mg, 100-mg, 150-mg, and 200-mg extended-release capsules. Qudexy XR cannot be prescribed if the patient has metabolic acidosis and is also taking metformin.

Upsher-Smith’s clinical development pipeline includes 2 investigational drugs that are being studied for the management of seizure disorders. The first is USL261, an investigational intranasal midazolam for the rescue treatment of seizures in patients who require control of intermittent bouts of increased seizure activity, often called seizure clusters. USL261 is the subject of an ongoing international phase 3 clinical trial, called ARTEMIS1, with an open-label safety extension study.  The company’s other investigational drug is USL260 (tonabersat), which is in early clinical development as a potential first-in-class neuronal gap junction modulator.