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 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.
Withdrawal of marketing authorisation
In February 2016, the European Medicines Agency (EMA) had withdrawn its marketing authorisation for Nuedexta in the EU.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, who developed the drug and manufacture it. 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.
Avanir have written to us to explain the reasons for their decision. They cite commercial considerations: they do not feel that they will be able to market Nuedexta profitably in the EU, taking into account the regulatory environment and the prices paid for drugs by health services across Europe.
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 USA.
While it’s disappointing that a drug aimed at treating the symptoms of MND won’t be available to patients, in practice the impact on people living with MND will be marginal at most. Emotional lability is already commonly managed with antidepressants such as citalopram, and our discussions with leading MND neurologists have indicated that many were not actively considering using Nuedexta – and even those that were saw it as a potential second-line treatment at best. At present, Nuedexta therefore seems to represent nothing more and nothing less than an additional option for symptoms that can be managed by other means. However, we’ll be writing to the manufacturer to express our disappointment, and seek an assurance that they will bring Nuedexta back to market in the EU if it is later found to have any further benefits.Dr Brian Dickie, Director of Research Development