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The NDA submission was partly based on topline results from the ongoing single location BHV4157-206-RWE study (NCT06529146), in which troriluzole 200 mg administered orally once daily led to a 5070% slower rate of decline from baseline in the functional Scale for the Assessment and Rating of Ataxia (f-SARA) in all SCA genotypes at 3 years compared to an external control arm. Data from the BHV4157-206 study (NCT03701399) also demonstrated disease stabilization in the SCA3 genotype and a reduction in falls in all SCA genotypes compared to placebo over 48 weeks. If approved, troriluzole will be the first and only medication indicated for the treatment of SCA
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Ingredients Peanuts, Corn Syrup Solids, Sugar, Pea Protein, Contains 2% Or Less Of: Salt, Fully Hydrogenated Vegetable Oils (rapeseed And Soybean), Mono And Diglycerides, Molasses, Magnesium Oxide, Niacinamide, Ferric Orthophosphate, Zinc Oxide, Copper Sulfate, Pyridoxine Hydrochloride, Folic Acid
Preliminary research suggests it may influence incretin hormone pathways, though clinical evidence supporting meaningful GLP-1 or GIP enhancement in humans is lacking
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