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Avanir’s week goes from bad to worse with Alzheimer’s stumble

Suffers a blow as second phase 3 trial misses the mark


Otsuka’s Avanir unit has been dealt yet another setback after its second phase 3 trial of its new drug for agitation in Alzheimer’s disease missed the mark.

The study of AVP-786 – a new formulation of the active ingredients in its already-marketed Nuedexta (deudextromethorphan hydrobromide/quinidine sulphate) product – was unable to show that the drug was able to reduce moderate-to-severe agitation in AD patients, missing both the primary and secondary endpoints.

An earlier trial of the drug seemed to suggest it was able to achieve a significant reduction in agitation symptoms at one of two doses tested, described by Otsuka as “encouraging” when the top-line results were released in March.

The results are a big blow to Avanir, and came just a few days after the company agreed to pay $116m in civil and criminal penalties for paying kickbacks to doctors to induce doctors to prescribe Nuedexta, which is approved to treat pseudobulbar affect – uncontrolled laughing or crying – in neurological diseases such as multiple sclerosis or brain injury.

The US Department of Justice said on Friday that Avanir had encouraged prescribing of Nuedexta for unapproved uses, including agitation in AD, and took advantage of a drive to reduce the prescribing of antipsychotic drugs to dementia patients in nursing homes.

A report by CNN claims that sales of Nuedexta increased five-fold to $300m in 2018 as a result of the mis-prescribing, with around half those revenues coming from use of the drug in elderly care facilities.

AVP-786 is a second-generation version of Nuedexta, modified by the addition of deuterium into the dextromethorphan molecule. That is thought to reduce the metabolism of dextromethorphan in the liver, prolonging its exposure in the blood. It was granted a fast track designation by the FDA in 2015 for AD-related agitation.

Avanir’s R&D head Sanjay Dubé said the results of the AVP-786 trial were a major disappointment, given the “significant unmet medical need for treating agitation in patients with Alzheimer’s dementia, as currently there are no FDA-approved treatments”.

Many patients with Alzheimer’s will experience agitation at some point, characterised by restlessness, being unable to sleep, pacing back and forth and in severe cases verbal and/or physical aggression that causes emotional distress to patients and carers.

APV-786 is also being studied in mid-stage trials as a possible treatment for schizophrenia, intermittent explosive disorder and traumatic brain injury, according to Avanir’s current pipeline table. For now, there’s no word on the fate of those programmes.

Otsuka paid $3.5bn to acquire Avanir in 2014 as part of a strategy to expand its presence in the central nervous system (CNS) disease category in the US. At the time, it said AVP-786 was one of the main attractions of the business.

Shares in the Japanese company plunged 14% in the wake of the new trial announcement, while Concert Pharmaceuticals – which out-licensed the drug to Avanir – was also hit hard.

Article by
Phil Taylor

1st October 2019

From: Research



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