FDA Grants Tentative Approval to Migraine Prevention Drug

The FDA recently granted tentative approval for Upsher-Smith Laboratories, Inc’s Qudexy XR (topiramate) for the prevention of migraine headaches.

The drug is currently approved for monotherapy and adjunctive therapy in patients 2-years-old and up with partial-onset or primary generalized tonic-clonic seizures, or seizures from Lennoz-Gastaut syndrome.

Treatment with Qudexy XR can potentially cause serious eye problems that can result in blindness if untreated, decreased sweating and fever, metabolic acidosis, high blood ammonia levels, kidney stones, low body temperature, and can have an effect on thinking.

"Topiramate is the molecule prescribed most frequently by neurologists for the prevention of migraines. However, there are currently no extended-release topiramate formulations approved for migraine prophylaxis in the US," concluded William Pullman, MB, BS, BMedSc, PhD, FRACP, chief scientific officer and Biotech Research Institute Division president of Upsher-Smith. "We look forward to bringing this treatment option to the migraine community, and will continue to work with the FDA to gain final approval."