Qudexy XR (topiramate) Approved for Migraine Prophylaxis

Qudexy XR, manufactured by Upsher-Smith Laboratories, Inc., originally received approval in June 2014. The medication, with the active ingredient topiramate, was indicated for use as an initial monotherapy or adjunctive therapy in patients two years old and older who have primary generalized or partial-onset tonic-clonic seizures, as well as for seizures associated with Lennox-Gastaut syndrome. Qudexy XR received temporary approval in April 2016, however, has just received full approval from the US FDA this week for use as prophylaxis of migraine in individuals 12 years of age and older.

The active ingredient in Qudexy XR has a “top tier” rating from the American Headache Society and the American Academy of Neurology for adult migraine prevention. Qudexy XR is an extended-release capsule that can be taken with or without food, and at any time of day, to provide a consistent, and smooth 24-hour treatment. The capsules can even be broken open and sprinkled onto soft food for easier consumption.

“Topiramate is a first-line, Level A migraine medication, and the expanded indication for migraine prevention in adolescent and adult patients for once-daily Qudexy® XR is a great addition to our treatment options. The unique extended-release formulation of Qudexy® XR will allow for smoother delivery of topiramate than was previously possible.” - Brian D. Loftus, MD, Board Certified in Headache Medicine, President of the Southern Headache Society

Qudexy XR is not indicated for individuals who are also taking metformin or who have metabolic ketoacidosis. Individuals wanting to take Qudexy XR should tell their provider about all other medical conditions, if they are pregnant or planning to become pregnant, and any other medications they are taking, including medications that impact mental performance or seizures, before they begin taking Qudexy XR.

Some serious side effects can come with Qudexy XR, including:
• Eye problems, including increased eye pressure and blurred vision
• Decreased sweating and fever
• Kidney stone formation
• Low body temperature
• Suicidal thoughts and actions
• Fetal harm
• Dizziness or loss of muscle control
• Effects on thinking and alertness
• Increased acid concentration in blood, which can affect bone strength
• High ammonia level in the blood which could slow alertness and mental activities

There is a support program for Qudexy XR, which helps individuals start, stay on, and pay for the medication, and also helps with co-pay assistance. This program is called the Access Pathways Program, and can be found at QudexyXR.com.

Reference: “FDA approves extended indication for Qudexy XR (topiramate) extended-release capsules to include prophylaxis of migraine headache in adults and adolescents.” PR Newswire. 30 Mar 2017. Available here.

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