ACADIA Pharmaceuticals Inc. announced the initiation of the Phase 3 CLARITY-2 study and plans to initiate the Phase 3 CLARITY-3 study in the upcoming months. These studies will evaluate the efficacy and safety of pimavanserin as adjunctive treatment in patients with major depressive disorder (MDD) who have an inadequate response to standard antidepressant therapy with either a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI). Pimavanserin is a selective serotonin inverse agonist preferentially targeting 5-HT2A receptors, which may play a role in depression.
“We are pleased to announce the initiation of the Phase 3 CLARITY program. The results observed in the original Phase 2 CLARITY study showed significant promise for patients with MDD, including a significant antidepressant response, improvement in disability, decreased daytime sleepiness, no meaningful weight gain, and improved sexual function,” said Serge Stankovic, M.D., M.S.P.H., ACADIA’s President. “We believe pimavanserin has the potential to be a very important treatment option for the millions of MDD patients where there remains unmet medical need. Based on feedback we received from the U.S. FDA, if we’re successful in the Phase 3 program, we plan to use the Phase 2 CLARITY study and positive study results from at least one of these two Phase 3 studies to support a supplemental NDA submission.”