Upsher-Smith announced that the Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Qudexy XR (topiramate) extended-release capsules for use as initial monotherapy in patients aged ≥2 years with partial-onset seizures or primary generalized tonic-clonic seizures.
Qudexy XR is a broad-spectrum antiepileptic that can be sprinkled onto soft food for administration in younger children who may have difficulty swallowing whole capsules or tablets. Topiramate is thought to work via the following mechanisms: block voltage-dependent sodium channels, augment the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A receptor, antagonize the AMPA/kainate subtype of the glutamate receptor, and inhibit the carbonic anhydrase enzyme, particularly isozymes II and IV.
Qudexy XR was initially approved for use as initial monotherapy in patients ≥10 years with partial-onset seizures or primary generalized tonic-clonic seizures; and as adjunctive therapy in patients aged ≥2 years with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome.
Qudexy XR is supplied in 25mg, 50mg, 100mg, 150mg, and 200mg strength capsules in 30-, 90-, and 500-count bottles.
For more information call (800) 657-7613 or visit QudexyXR.com.