Sharing information at the symposium is what it’s all about. Today, Randall Kaye, chief medical officer from Avanir Pharmaceuticals, chose the symposium to give a presentation on a newly approved FDA drug for emotional lability (uncontrollable laughter and crying) called Nueudexta. Emotional lability is a symptom that is experienced by some people living with MND.
Nuedexta is actually a combination of two drugs, dextromethorphan and quinidine, that are already quite well known. In a clinical trial involving over 300 people with MND or multiple sclerosis, Nuedexta was found to significantly reduce the frequency and severity of episodes of uncontrollable laughter and crying. As Nuedexta has recently been approved by the FDA, this symposium gave Avanir Pharmaceuticals the opportunity to provide delegates with an overview of Nuedexta and guidelines on how it should be used.
We have been told by Avanir Pharmaceuticals that talks will begin with the European regulatory authorities in 2011. It is not yet possible to say when Nuedexta will be available to people with MND in the UK.
We will keep you posted as soon as we hear developments on the availability of this drug in the UK.
Emotional lability is one of my most annoying symptoms, I can’t talk, eat or drink which makes socialising less fun than it used to be. The embarrassment of crying when watching a Huddersfield Town game because they play well and I’m just pleased or proud that they are seems as ridiculous to me as those who notice. My children know this is a symptom of MND but the fact I might be embarrasing them makes me cry even more! All seems crazy!
The above is just a moan about why I want to try Nuedexta. I really do appreciate the work of the MND Association but I’d like to see some sort of comment displaying the intention to push for making Nuedexta available in the UK rather than words that suggest we’ll just have to wait and see!
Keep up the good work
Cheers
Ian
Hi Ian – You are a lot closer now, hopefully it will be available within the next 9 months or sooner.
ALISO VIEJO, Calif., April 26, 2013 /PRNewswire/ — Avanir Pharmaceuticals, Inc. (AVNR) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for NUEDEXTA® (dextromethorphan hydrobromide and quinidine sulfate), recommending NUEDEXTA be approved for the treatment of pseudobulbar affect (PBA), irrespective of neurologic cause. In addition, the CHMP also recommended approval of two dose strengths of NUEDEXTA; 20/10 mg and 30/10 mg capsules.
I have followed the progress of Nuedexta in the USA for 8 years, rest assured all that could be done was done by Avanir to obtain a positive CHMP recommendation. It should be rubber stamped by the EC within 67 days of the above date.
For your information Nuedexta is currently undergoing clinical trials for further indications.
Very best regards.
Owen