Upsher-Smith Laboratories, Inc. has received approval from the 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 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. More information is available at www.qudexyxr.com.
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 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.
"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, M.D., 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." Qudexy XR is available in 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg extended-release capsules.