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Phase III Study Failure Clouds Future Of Avanir’s Alzheimer’s Agitation Candidate

 
• By Ian Haydock

Otsuka’s Avanir hit by failed second trial in Phase III program with candidate for agitation associated with Alzheimer’s, prompting a re-think of development plans and potentially helping rivals in a high-need indication.  

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Setback For Avanir's Alzheimer's Agitation Candidate • Source: Shutterstock

Avanir Pharmaceuticals Inc.’s AVP-786 has failed in a Phase III North American study investigating its use in moderate-to-severe agitation in patients with Alzheimer’s dementia, prompting the California-based Otsuka Pharmaceutical Co. Ltd. subsidiary to reassess the continued development path for the molecule.

The second study (15-AVP-786-302 or TRIAD-2) was part of the company’s Phase III program investigating the therapy, which is a combination of deudextromethorphan hydrobromide (d6-DM) and an ultra-low dose of quinidine sulfate. While Avanir did not disclose detailed results, it said the trial did not meet its primary or key secondary endpoints

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