Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced one late-breaker oral platform presentation and two poster presentations to be presented at the International Congress of Parkinson’s Disease and Movement Disorders^® being held October 5-9, 2025, in Honolulu, Hawaii.

The presentations highlight updates from the company’s robust pipeline including preclinical efficacy, safety and mechanism of action findings on Acadia’s investigational drug ACP-711, under development for essential tremor, as well as a report on the study design of the Phase 2 ACP-204 study in adults with Lewy body dementia psychosis. The company will also present encore findings from a post-hoc analysis of clinical trial data evaluating duration of illness and response to NUPLAZID^® (pimavanserin) in Parkinson’s disease psychosis.

Late-Breaker Oral Platform Presentation:

• Session OPP9/Abstract LBA9/Room 315: Mechanism of Action, Preclinical Efficacy, and Safety Evaluation of SAN711/ACP-711, a Novel GABA_A Subunit α₃ Selective Modulator, Wednesday, October 8 at 12:00-1:00 p.m. HST

Poster Presentations:

• E-Poster 1229: Design of the Phase 2, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of ACP-204, a Novel 5-HT2A Inverse Agonist/Antagonist, in Adults with Lewy Body Dementia Psychosis Tuesday, October 7 at 12:18 p.m. HST
• E-Poster 1225: Duration of Illness and Response to Pimavanserin in Parkinson’s Disease Psychosis: Post-Hoc Analysis of Clinical Trial Data, Tuesday, October 7 at 12:06 p.m. HST

About NUPLAZID^® (pimavanserin)

Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID.

Indication

NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.

Important Safety Information

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
• NUPLAZID is not approved for the treatment of patients with dementia who experience psychosis unless their hallucinations and delusions are related to Parkinson’s disease.

• Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
• Warnings and Precautions: QT Interval Prolongation
  • NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval (e.g., Class 1A antiarrhythmics, Class 3 antiarrhythmics, certain antipsychotics or antibiotics).
  • NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval.
• Adverse Reactions: The adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%).
• Drug Interactions:
  • Coadministration with strong CYP3A4 inhibitors increases NUPLAZID exposure. Reduce NUPLAZID dose to 10 mg taken orally as one tablet once daily.
  • Coadministration with strong or moderate CYP3A4 inducers reduces NUPLAZID exposure. Avoid concomitant use of strong or moderate CYP3A4 inducers with NUPLAZID.

Dosage and Administration

Recommended dose: 34 mg capsule taken orally once daily, without titration, with or without food.

NUPLAZID is available as 34 mg capsules and 10 mg tablets.

Please read the full Prescribing Information, including Boxed WARNING, also available at NUPLAZIDhcp.com.

About Acadia Pharmaceuticals

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference. For more information, visit us at acadia.com and follow us on LinkedIn and X.

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