Upsher-Smith’s Antiepileptic Secures Expanded Indication

Upsher-Smith’s Qudexy XR is now available as a first-line monotherapy for children ages two and older who have partial-onset or tonic-clonic seizures.

The FDA’s seal of approval, announced last week, makes Qudexy XR (topiramate extended-release capsules) the first once-daily extended-release topiramate product to win this indication. Parents can open the capsules and sprinkle the drug over soft food, making it a more viable treatment option for very young children who may not yet be able to swallow pills, the drugmaker says.

The broad-spectrum antiepileptic has been available for a year for patients 10 years and older with partial-onset or primary generalized tonic-clonic seizures and as an adjunct therapy for children two years and older with either type of seizure or seizures associated with Lennox-Gastaut Syndrome. — Lena Freund