Acadia’s pimavanserin falls short at Phase 3 in major depressive disorder

pharmafile | July 21, 2020 | News story | Manufacturing and Production, Research and Development Acadia Pharmaceuticals, major depressive disorder, phase 3, trial failure 

Acadia Pharmaceuticals has lifted the lid on new Phase 3 for its therapy pimavanserin, revealing that the drug unfortunately failed to hit its main goal as an adjunctive treatment for major depressive disorder (MDD).

Through data harvested from two identical, double-blind, placebo-controlled studies of 298 participants, it was found that the drug fell short of its primary goal. A once-daily dose of 34mg, given as an adjunct to standard antidepressant therapy generated a mean reduction of 9.0 on the 17-item Hamilton Depression Rating Scale (HAMD-17) total score compared to a change of 8.1 with placebo.

This was unfortunately statistically insignificant to hit the main study goal of a change from baseline to week 5 on the scale.

However, the study did report positive results for its key secondary endpoint of a change on the Clinical Global Impression – Severity scale, a tool used by clinicians to assess severity of a patient’s depression.

“We observed a consistent improvement of depressive symptoms over time with pimavanserin but, unfortunately, the robust positive results from our CLARITY-1 study were not replicated,” explained Serge Stankovic, Acadia’s President. “While these results do not support the product profile to pursue an additional Phase 3 study in adjunctive MDD, we will continue to analyse the data and the findings from our earlier positive depression studies as we assess next steps.”

Matt Fellows

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