On March 11, 2014 the FDA approved Topiramate, marketed as Qudexy™ XR by Upsher-Smith Laboratories, for the treatment of partial-onset seizures (POS) or primary generalized tonic-clonic seizures in patients 10+ years of age. It is also approved as adjunctive therapy in patients 2+ years of age for the aforementioned seizures, and seizures associated with Lennox-Gastaut syndrome.
The FDA approval was based on the phase III PREVAIL trial data, released late 2013 at the American Epilepsy Society 67th Annual Meeting.
Precisely 249 adult patients around the world participated in the PREVAIL trial, throughout at 66 centers. Trial results revealed the drug’s endpoints were met for efficacy. A significantly greater median percentage reduction in seizure frequency was observed compared with the placebo (39.5% vs 21.7%; P < .001.) The 50% responder rate was also greater (37.9% vs 23.2%; P = .013).
The new topiramate formulation can be prescribed in 25mg, 50mg, 100mg, 10mg, and 200mg extended-release capsules. The capsule contents can be sprinkled on soft food like applesauce to help dosing for patients who have a hard time swallowing the whole pill.
Upsher-Smith Laboratories President & CEO, Mark Evenstad said the FDA approved antiepileptic drug is a major milestone for the company, as this is the first branded CNS product in their portfolio.
Epilepsy is a medical condition that is characterized by recurrent seizures. More than 2 million people in the U.S. are estimated to be affected by epilepsy with about 200,000 new cases of epilepsy diagnosed each year. Epilepsy can be associated with profound physical, psychological and social consequences that negatively impact people’s lives.
LGM Pharma provides Topiramate CAS# 97240-79-4 for research and development purposes. Clients can be assured of quality API products and offer continuous support throughout the R&D process.
Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.