Two Supplemental New Drug Applications for Migraine Drug Topiramate Win FDA Approval

Qudexy XR Extended-Release Capsules for migraine headache gets FDA approval.

The US Food and Drug Administration (FDA), today approved 2 supplemental new drug applications (sNDAs) for topiramate (Qudexy/Upsher-Smith Laboratories) Extended-Release Capsules to prevent migraine headaches in adults and adolescents 12 years and older.

According to neurologists and members of the American Academy of Neurology and the American Headache Society, topiramate is the molecule frequently prescribed to prevent migraines.

Researchers hope to conduct a study to address post-marketing requirements in the United States to evaluate the safety and efficacy of Qudexy XR for the treatment of migraines in pediatric patients ages 6-11.

Qudexy XR capsules provide adolescents and adults with migraines a once-daily prophylactic medication that can be taken morning or night, with or without food. However, reports show that adherence to migraine prophylaxis medications is as low as 41% at 2 months and declines even further over time.

Qudexy XR was specifically engineered to deliver a smooth pharmacokinetic profile and has been shown to reduce the “peak-to-trough fluctuation of topiramate plasma concentrations,” which is linked to immediate-release topiramate.

“Qudexy XR capsules can be swallowed whole or opened and the beads sprinkled onto a spoonful of soft food is swallowed. The unique extended-release formulation of QudexyXR will allow for smoother delivery of topiramate than was previously possible,” said Brian D. Loftus, MD, Board Certified in Headache Medicine, President of the Southern Headache Society, in a news release.

The most commonly reported adverse events of Qudexy XR include: paresthesia, loss of hunger, weight loss, nervousness, nausea, speech problems, fatigue, dizziness, sleepiness/drowsiness, change in food taste, upper respiratory tract infection, slow reactions, difficulty with memory, fever, abnormal vision, diarrhea, and abdominal pain.

Qudexy XR has been available in the United States since June 2014 and was approved for use in the following treatments:

· As an initial monotherapy in patients 2 years and older who experienced partial-onset or primary generalized tonic-clonic seizures

· As adjunctive therapy in patients in patients 2 years and older with partial-onset or primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome.

Officials reported that a savings and support program is available to patients who have been prescribed Qudexy XR — the Access Pathways Program actually offers co-pay assistant and administrative support to help patients start, stay, and save on Qudexy.