The US Food and Drug Administration (FDA) has not yet approved a drug for the treatment of agitation in Alzheimer’s disease. Avanir’s drug, AVP-923, is a combination of the cough medicine dextromethorphan and quinidine, a drug used to treat abnormal heart rhythms. AVP-923 has already been approved for the treatment of ‘pseudobulbar effect’, which is characterized by ‘easy laughing and crying’. It is currently marketed as Nuedexta (dextromethorphan/quinidine) in the US [1].

Treatment of Alzheimer’s patients with AVP-923 was associated with significantly reduced agitation and aggressive outbursts compared with placebo.

Agitation in Alzheimer’s disease and the pseudobulbar effect are not the only indications that Avanir are looking at with this combination drug. In a presentation to the 38th Annual dbAccess Health Care Conference in May 2013, Avanir CEO Keith Katkin described Nuedexta as a ‘pipeline in a pill’. Mr Katkin said that ‘given the mechanism of Nuedexta, we’re able to study Nuedexta in a number of additional potential indications including various forms of pain, various mood and behaviour disorders as well as movement disorders, and we have program[me]s in all three of those areas currently ongoing’.

It remains unclear how FDA, physicians and patients will respond to a new drug composed of two old drugs. It is thought that some members of Congress are likely to object to any attempts to tie a high price to something like this. Nevertheless, an Avanir spokesperson said that a potential new treatment option for the alleviation of agitation or aggression related to Alzheimer’s disease would have a significant impact on the daily life of patients and their caregivers.

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Reference
1.   GaBI Online - Generics and Biosimilars Initiative. Avanir and Wockhardt settle Nuedexta patent dispute [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 3]. Available from: www.gabionline.net/Generics/News/Avanir-and-Wockhardt-settle-Nuedexta-patent-dispute

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