The MAA includes Nuedexta phase 3 studies clinical data of in patients with PBA and also includes data from the company’s longer-term safety studies.
Nuedexta comprises dextromethorphan hydrobromide (20 mg), an ingredient active in the central nervous system, and quinidine sulfate (10 mg), a metabolic inhibitor enabling therapeutic dextromethorphan concentrations.
NUEDEXTA acts on sigma-1 and NMDA receptors in the brain and treats PBA.