Upsher - Smith Laboratories, Inc. (Upsher - Smith), a growing pharmaceutical company dedicated to its mission of advancing pharmacotherapy, has received approval from the US 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. 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 offer s 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, 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.”
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 centres.
Results from the PREVAIL study showed that the drug met its endpoints for efficacy and demonstrated favourable safety and tolerability in epilepsy patients with refractory POS . The findings demonstrated t hat 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.
Epilepsy is a medical condition that is characterized by recurrent seizures . More than two million people in the US 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.
In addition to the recently - approved Qudexy XR, Upsher - Smith’s clinical development pipeline includes two investigational drugs that are being studied for the management of seizure disorders. The pipeline includes 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, which is the subject of an ongoing international phase 3 clinical trial (ARTEMIS1) with an open - label safety extension study. In addition, USL260 (tonabersat) is in early clinical development as a potential first - in - class neuronal gap junction modulator.