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ACADIA Pharmaceuticals Announces that The Journal of Clinical Psychiatry Publishes Positive Phase 2 CLARITY Results for Pimavanserin as Adjunctive Treatment for Patients with Major Depressive Disorder
- Pimavanserin as an adjunctive treatment for patients with MDD showed significant overall improvement in HAMD-17 total score compared to placebo - Phase 3
About this update from Acadia Pharmaceuticals Inc.
[{"type":"text","content":"\n- Pimavanserin as an adjunctive treatment for patients with MDD showed significant overall improvement in HAMD-17 total score compared to placebo\n\n\n- Phase 3 CLARITY program initiated in April 2019\n\n SAN DIEGO--(BUSINESS WIRE)--\nACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), announced today that positive results from the Phase 2 CLARITY study evaluating pimavanserin as adjunctive treatment in patients with major depressive disorder (MDD) have been published online by The Journal of Clinical Psychiatry, the official journal of the American Society of Clinical Psychopharmacology (ASCP). In this 10-week, randomized, double-blind, placebo-controlled study (n=207), pimavanserin met the overall primary endpoint of the study by significantly reducing the 17-item Hamilton Depression Rating Scale (HAMD-17) total score compared to placebo (p=0.039). In the parallel design portion (Stage 1) of this two-stage sequential parallel comparison design (SPCD) study, adding pimavanserin to first-line SSRI or SNRI therapy also significantly reduced HAMD-17 scores compared to placebo (p=0.0003). On the key secondary endpoint, pimavanserin also demonstrated statistically significant reductions compared to placebo in the Sheehan Disability Scale (SDS) score (p=0.004).\n\n\nThe study published today, “A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients with Major Depressive Disorder and an Inadequate Response to Therapy (CLARITY),” also included positive overall results observed for additional secondary study endpoints with nominal p-values including: Clinical Global Impression-Severity (p=0.0084), Clinical Global Impression-Improvement (p=0.0289), Karolinska Sleepiness Scale (p=0.0205), Massachusetts General Hospital Sexual Functioning Index (p=0.0003), and Barratt Impulsiveness Scale (p=0.0075). Pimavanserin was well-tolerated in the study and the most common adverse events reported in the pimavanserin group were dry mouth, nausea, and headache all with frequency of less than 10%.\n\n\n“Today, the standard of care in MDD is to start patients on SSRI or SNRI therapies. However, a majority of patients do not adequately respond to these initial treatments and are prescribed an adjunctive therapy to manage their symptoms,” said Professor Maurizio Fava, M.D., Executive Vice Chair, Department of Psychia...