FDA Okays Topiramate ER (Qudexy) Monotherapy in Children

Pauline Anderson


June 03, 2015

Extended-release topiramate (Qudexy, Upsher-Smith) has received US Food and Drug Administration (FDA) approval as an initial monotherapy in patients as young as 2 years with partial-onset seizures or primary generalized tonic-clonic seizures, the company has announced.

Topiramate was previously approved in March 2014 for use as initial monotherapy in patients 10 years of age and older with partial-onset seizures or primary generalized tonic-clonic seizures, and as adjunctive therapy in patients 2 years of age or older with partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome.

The once-a-day capsules are the only extended-release topiramate product to have received this expanded indication, according to a press release from Upsher-Smith.

Extended release topiramate is a broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile. The contents of the capsules can be sprinkled onto soft food.

This makes them a "viable treatment option" for young children who may have difficulty swallowing whole capsules or tablets, said William Pullman, PhD, chief scientific officer, Upsher-Smith.

The most common adverse effects of this drug include paresthesia, weight loss, nervousness, speech problems, tiredness, dizziness, drowsiness, slow reactions, difficulty with memory, fever, and abnormal vision.

Similar to other antiepileptic drugs, it may cause suicidal thoughts or actions in a small number of people (about 1 in 500). The drug may cause serious eye problems that can lead to permanent loss of vision if not treated. It may also cause decreased sweating, fever, or metabolic acidosis. Patients with metabolic acidosis who are taking metformin should not be prescribed this drug.

Topiramate passes into breast milk, and it is not known whether it can harm a breast-feeding infant. It may also make birth control pills less effective.

A savings and support program is available to patients who have been prescribed extended-release topiramate. For more information can be found at SaveonQudexyXR.com.


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