Industry Briefs

Acadia Initiates Phase 3 Study of Pimavanserin for Dementia-Associated Psychosis

Acadia Pharmaceuticals Inc. has announced the initiation of HARMONY, a phase 3 study to evaluate the efficacy and safety of pimavanserin (Nuplazid) for the treatment of psychosis in patients with Alzheimer’s disease, dementia with Lewy bodies, and other forms of dementia. Nuplazid, a selective serotonin inverse agonist, was first approved by the Food and Drug Administration in April 2016 for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

The study will include a 12-week open-label stabilization period during which patients will receive 34 mg pimavanserin once daily; dose reduction to 20 mg will be allowed if needed.

Patients who show a response will be randomized into a 26-week double-blind study and continue their pimavanserin dose or be switched to placebo. The primary endpoint in the study is time to psychosis relapse.

Otsuka Partners With Digital Health Company to Improve Efficacy of Abilify

Otsuka Pharmaceuticals has partnered with digital health company Medibio to help assess the effectiveness of its antipsychotic Abilify (aripiprazole).

Otsuka is paying Medibio to apply its proprietary digital platform to characterize key circadian, autonomic, and sleep biomarkers from an existing clinical dataset of Abilify users. The goal is to identify biomarkers related to efficacy, which Otsuka can use in future clinical trials.

This is the second digital partnership for Otsuka. The company is collaborating with Proteus Digital Health to create an Abilify pill that contains an ingestible sensor and has recently resubmitted a New Drug Application for this pill-sensor combo therapy.