Once-Daily Topiramate Approved for Migraine Prophylaxis

Pauline Anderson


March 31, 2017

The US Food and Drug Administration (FDA) has given final approval to two supplemental new drug applications (sNDAs) for topiramate extended-release capsules (Qudexy XR, Upsher-Smith Laboratories Inc) to prevent migraine in adults and adolescents aged 12 years and older, the company has announced.

The capsules can be taken morning or night, with or without food. They can be swallowed whole or opened and sprinkled onto soft food for easier swallowing.

Upsher-Smith was granted tentative approval of its sNDA in April 2016 but was not eligible to receive final approval until after the innovator drug's exclusivity for the adolescent population expired in March of this year. 

The expanded indication of once-daily topiramate for migraine prevention "is a great addition to our treatment options," said Brian D. Loftus, MD, president of the Southern Headache Society, in a press release.

Topiramate is the drug prescribed most frequently by neurologists for the prevention of migraines, said the press release. The American Academy of Neurology and the American Headache Society have both given this molecule a "top tier" rating for migraine prevention in adults, it added.

The extended-release capsules have been engineered to deliver a smooth pharmacokinetic profile and have been shown to reduce the peak-to-trough fluctuation of topiramate plasma concentrations that are associated with immediate-release formulations of the drug, according to the press release.

The "unique" extended-release formulation "will allow for smoother delivery of topiramate than was previously possible," said Dr Loftus.

The extended-release drug may improve adherence. According to the company, adherence to migraine prophylaxis medications is reported to be as low as 41% at 2 months and declines even further over time.

The company is planning a study to evaluate the efficacy and safety of topiramate XR for the prophylaxis of migraine in pediatric patients aged 6 to 11 years.

Epilepsy Indication

Topiramate XR is also approved as a monotherapy in patients 2 years of age and older with partial-onset or primary generalized tonic-clonic seizures. As well, it's approved as an adjunctive therapy in those in the same age category with partial-onset or primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome.

According to background information provided by the company, topiramate XR may make birth control pills less effective and should not be prescribed to patients with metabolic acidosis who are also taking metformin.

In addition to metabolic acidosis, potentially serious side effects of the drug may include eye problems (such as blurred or sudden decrease in vision and increased pressure in the eye), decreased sweating and fever, high ammonia levels in the blood, kidney stones, low body temperature, dizziness, fetal harm, and suicidal thoughts.

Topiramate XR should not be taken in combination with alcohol. Patients using this medication should not drive, swim, climb, or operate heavy machinery until it's known how it affects them.

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