On 27 September, Avanir Pharmaceuticals, a pharmaceutical company committed to delivering innovative central nervous system solutions, announced top-line data from its Phase III 15-AVP-786-302 study for the treatment of agitation in people with Alzheimer’s dementia. The study enrolled 522 US and Canadian participants aged 50-90 years old with a diagnosis of probable Alzheimer’s dementia and clinically moderate or severe agitation. They were randomised to receive AVP-786 or placebo orally twice a day during 12 weeks.
The company reported that the study failed to meet its primary endpoint. Participants treated with AVP-786 did not experience a statistically significant improvement in agitation compared to participants treated with placebo, as measured by the Cohen-Mansfield Agitation Inventory (CMAI). Similarly, the study did not meet its key secondary endpoints. The most common adverse events that occurred in participants receiving AVP-786 versus placebo were falls, urinary tract infection and somnolence. No deaths were considered related to treatment. Avanir Pharmaceuticals is conducting another Phase III clinical trial (17-AVP-786-305) with AVP-786 for the treatment of agitation in people with Alzheimer’s dementia. Approximately 400 participants will be enrolled in US, Australia and Europe.
