Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Avanir Pharmaceuticals has submitted marketing authorization application to the European Medicines Agency (EMA) for Nuedexta used to treat pseudobulbar affect (PBA).
Subscribe to our email newsletter
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.