What does the drug do?
Nuedexta is a drug that treats emotional lability (‘pseudo-bulbar affect’, or PBA) in MND and other neurological conditions. Emotional lability can be described as inappropriate emotional expression often characterised by uncontrollable laughing or crying; it is a feature of MND and some other neurological conditions.
Nuedexta was shown to be effective in treating emotional lability. However, the drug is not available for patients in the UK and EU.
Marketing Authorisation in the UK
Nuedexta was originally granted a marketing authorisation by the EMA in July 2013, but Avanir Pharmaceuticals Inc, the company who developed and manufacture the drug, did not take the further necessary steps to make it available in the UK, such as agreeing a price with the NHS under the Pharmaceutical Prices Regulation Scheme.
In February 2016, the European Medicines Agency (EMA) had withdrawn its marketing authorisation for Nuedexta in the EU.
The withdrawal has been made at the request of Avanir Pharmaceuticals Inc. Avanir have never made the drug available in Europe, and this decision means that it is not available to prescribe for patients in the EU.
Because Nuedexta is a patented medicine, Avanir has the sole right to produce and distribute it; it will not be possible for another company to make it or for it to be imported into the EU – although it remains available in the US.
A Phase 3 trial for the treatment of PBA in patients with ALS. The results of the study, published in the scientific journal Neurology, revealed that Nuedexta was effective in reducing episodes of crying and laughing, and in improving the overall quality of life and relationships of patients with ALS. You can read more about the trial here.
Last updated: 21/12/2022