Acadia Pharmaceuticals reported negative results Monday from a pair of late-stage clinical trials seeking to expand the use of its antipsychotic medicine Nuplazid to patients with major depressive disorder.
The two identically designed Phase 3 clinical trials involved 300 patients who hadn’t responded well to currently approved depression treatments. In both studies, Nuplazid failed to demonstrate an anti-depressive benefit compared to a placebo when given to patients alongside their current medicines.
Patients given Nuplazid saw their scores on a measure known as the Hamilton Depression Rating Scale drop 9 points over 15 days, compared to a decrease of 8.1 points for those in the placebo group.
Depression studies are notoriously difficult to pull off successfully, and often require multiple attempts to achieve positive results. However, Acadia said it has no immediate plans to conduct another depression study at this time.
The FDA is currently reviewing Nuplazid as a treatment for hallucinations and delusions associated with dementia-related psychosis, with an approval decision date set for April 3, 2021.
Nuplazid is currently approved to treat reduce hallucinations and psychotic symptoms in people with Parkinson’s disease. Sales in 2019 totaled $339 million and are expected to reach $437 million this year.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.