Avanir Pharmaceuticals has announced that results from the phase II study evaluating AVP-923 for the treatment of agitation in patients with Alzheimer’s disease were presented at the 2014 American Neurological Association meeting.
In this study, utilising the two-stage, sequential parallel comparison design (SPCD), AVP-923 showed a clinically meaningful and statistically significant improvement in agitation on the primary endpoint and a majority of the secondary endpoints. Key highlights from the poster were:
- AVP-923 showed a statistically significant benefit on the agitation/aggression domain of the Neuropsychiatric Inventory (NPI) (primary endpoint; p=0.00008)
- The NPI agitation/aggression score was reduced by 3.3 points from baseline in AVP-923 treated patients at week five (stage 1; p=0.0002 vs. placebo) and was reduced by 2.0 points in stage 2 (p=0.021)
- The change in the NPI agitation/aggression score corresponds to a mean (SD) reduction from baseline of 47 percent (43.1 percent) for AVP-923 vs. 22% (50.8%) for placebo in Stage 1, and 26% (67.5%) for AVP-923 vs. 6.7% (77.9%) for placebo in Stage 2
- Treatment benefit with AVP-923 was evident at week one and was sustained for the duration of the 10-week study
- AVP-923 also demonstrated significant improvements versus placebo on the following outcomes: NPI total score (p=0.014), NPI4A (p=0.001), NPI4D (p<0.001), clinical global impression of change-agitation (p=0.0003), patient global impression of change (p=0.001) and measures of caregiver burden (p<=0.05)
- AVP-923 was generally safe and well-tolerated and associated with a low rate of discontinuation from the study (11.8%)
- Treatment with AVP-923 was not associated with cognitive decline or somnolence
“Agitation and aggression in Alzheimer’s disease are among the most disruptive of dementia-related neuropsychiatric symptoms and leading causes of institutionalisation,” says Jeffrey Cummings, director of the Cleveland Clinic Lou Ruvo Center for Brain Health, chair of the study steering committee and a paid member of Avanir Pharmaceuticals Advisory Board. “These study results are encouraging for Alzheimer’s patients suffering from agitation and their caregivers.”
“We are highly encouraged by these data showing a nearly 50% reduction in agitation for patients treated with AVP-923. In addition, clear improvements in global measures of agitation, as assessed by both clinicians and patients/caregivers, indicate the improvement was deemed clinically meaningful,” says Joao Siffert, chief medical officer for Avanir. “We are committed to working with regulatory agencies in the United States and the EU with the goal to advance the programme and make the treatment available as early as possible, upon approval, for patients with Alzheimer’s disease who have agitation.”
