Nuedexta for the treatment of pseudobulbar affect (in ALS patients)

Pseudobuldar affect is characterized by uncontrollable crying, laughter or other emotional displays. It can occur secondary to a neurological disorder or traumatic brain injury. The drug Nuedexta has been approved by the FDA in 2010 as a treatment option for pseudobulbar affect in patients with ALS or MS. However, in the EU Nuedexta has been deregistered since 2016 for market reasons according to the company. The question posed to the SBU Enquiry Service concerns what scientific studies that have documented the efficacy and safety of Nuedexta as a treatment of pseudobulbar affect in patients with ALS.