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FDA Approves Qudexy ER (topiramate) for Migraines

April 6, 2017
Once-daily formula is available for adults and children over 12; should help improve compliance.

The Food and Drug Administration has approved a supplemental new drug application for the once-daily formula of topiramate (Qudexy XR, Upsher-Smith Laboratories Inc) to prevent migraine in adults and adolescents age 12 years and older, the company announced in a press release.1

The extended-release drug may help improve patient 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.”1,2

The capsules can be taken with or without food, in the morning or night. Qudexy joins Topamax (Janssen Pharmaceuticals) as a topiramate formulations for the prevention of migraines (Table 1).3,4 Both agents are approved for use in adolescents.

Table 1. Prescribing Information for Topiramate Migraine Prophylaxis

Agent

Dosage

Topamax

25 mg per day administered nightly for the first week. The dosage should be increased weekly by increments of 25 mg. Dose and titration should be guided by clinical outcome. 100 mg per day administered in 2 divided doses

Qudexy XR

25 mg once daily at nighttime for the first week. Increase dose weekly by increments of 25 mg. Dosage and titration should be guided by clinical outcome. 100 mg once daily

 

Qudexy has been “specifically engineered to deliver a smooth pharmacokinetic profile and 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.

A study designed to address post-marketing requirements in the United States is planned to evaluate the efficacy and safety of Qudexy XR for the prophylaxis of migraine in pediatric patients ages 6 to 11.

Last updated on: April 6, 2017
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