The FDA has approved two supplemental new drug applications for Qudexy XR extended-release capsules, a once-daily prophylactic medication for migraine headache in adults and adolescents aged 12 years and older, according to a press release.
Although Upsher-Smith Laboratories Inc. received tentative approval of Qudexy XR (topiramate) in 2016, the supplemental new drug application was not eligible for final FDA approval until the drug’s exclusivity for the teen population expired in March.
“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,” Brian D. Loftus, MD, president of the Southern Headache Society, said in the release. “The unique extended-release formulation of Qudexy XR will allow for smoother delivery of topiramate than was previously possible.”
Qudexy XR has been shown to lower peak-to-trough fluctuation of topiramate plasma concentrations that are linked with immediate-release topiramate. The capsules provide adults and adolescents with an easy, once-daily migraine prophylaxis medication that can be taken morning or night, with or without food, according to the manufacturer. The capsule can be opened and sprinkled over food to enable easier delivery for patients who have difficulty swallowing whole capsules. This medication has been available in the United States since June 2014, the company said.
Use of Qudexy XR has also been approved as initial monotherapy in patients aged 2 years and older with partial-onset or primary generalized tonic-clonic seizures, and as adjunctive therapy in patients aged 2 years and older with partial onset or primary generalized tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome.
Adverse effects include serious eye problems, decreased sweating and fever, increased acid level in the blood, high ammonia level in the blood, kidney stone formation, low body temperature, effects of thinking and alertness, dizziness, fetal harm and suicidal thoughts and actions.