Upsher-Smith’s two sNDAs for Qudexy XR approved by FDA

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Upsher-Smith’s two sNDAs for Qudexy XR approved by FDA

By Brian Berk - 03/30/2017

MAPLE GROVE, Minn. — The Food and Drug Administration on Thursday approved Upsher-Smith Laboratories’ two supplemental new drug applications for Qudexy (toprimate) Extended-Release Capsules for use as prophylaxis of migraine headache in adults and adolescents 12 years of age and older.


Topiramate is the molecule that neurologists prescribe most frequently for the prevention of migraines, and the American Academy of Neurology and the American Headache Society have given topiramate a “top tier” rating for migraine prevention in adults.


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 6-11. 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.


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


Qudexy XR capsules offer adolescents and adults with migraines a once-daily prophylactic medication that can be taken morning or night, with or without food. The capsules have also been approved for administration by opening and sprinkling the contents onto a small amount of soft food, which may be helpful to patients who have difficulty swallowing whole capsules. It 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 topiramate.


Qudexy XR is also approved for use as initial monotherapy in patients 2 years of age and older with partial-onset or primary generalized tonic-clonic seizures and adjunctive therapy in patients two years of age and older with partial-onset or primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. Qudexy XR has been available in the United States since June 2014.


Upsher-Smith Laboratories, founded in 1919, is a fully integrated pharmaceutical company dedicated to its mission of delivering high-value, high-quality therapies and solutions which measurably improve individuals’ lives.


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