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ACADIA Pharmaceuticals to Present New Clinical Data and Outcomes Research at Upcoming Scientific Meetings

Business Wire 19-Sep-2019 9:00 AM

— New data presented at the International Congress of Parkinson's Disease and Movement Disorders will highlight treatment benefit of pimavanserin in patients with comorbid Parkinson's disease and depression

— New data presented at the Psych Congress will highlight improvement on sexual functioning observed in patients treated with adjunctive pimavanserin for major depressive disorder

ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) today announced it will present several scientific posters at the upcoming International Congress of Parkinson's Disease and Movement Disorders® on September 22-26, 2019 in Nice, France and at the annual Psych Congress on October 3-6, 2019 in San Diego, California.

Scientific poster presentations will highlight ACADIA's clinical and real-world research in central nervous system disorders with significant unmet need, including Parkinson's disease and Parkinson's disease psychosis, dementia-related psychosis, and major depressive disorder.

Scientific Presentations at the MDS Congress include:

  • Poster Number 163: Open-Label Study of Pimavanserin in Patients With Comorbid Parkinson's Disease and Depression presented on September 23, 2019, 1:45 – 3:15 p.m. CEST.
  • Poster Number 129: Use of Off-Label Antipsychotics Among U.S. Long-Term Care Residents With Parkinson's Disease Psychosis presented on September 23, 2019, 1:45 – 3:15 p.m. CEST.
  • Poster Number 204: Evaluating the Off-Label Use of Antipsychotics in Parkinson's Disease Psychosis Patients Within Large National U.S. Healthcare Databases presented on September 23, 2019, 1:45 – 3:15 p.m. CEST.
  • Poster Number 756: Healthcare Resource Utilization and Costs of Parkinson's Disease Dementia With Psychosis in the U.S. Medicare Population presented on September 23, 2019, 1:45 – 3:15 p.m. CEST.
  • Poster Number 1836: Comparison of Dementia Patients With and Without Parkinson's Disease Before Dementia-Related Psychosis Occurs: An Administrative Claims Data Analysis presented on September 25, 2019, 1:15 – 2:45 p.m. CEST.

Scientific Presentations at the Psych Congress include:

  • Poster Number 137: Improvement of Sexual Function Observed During Treatment of Major Depressive Disorder With Adjunctive Pimavanserin presented on October 4, 2019, 1:30 – 3:00 p.m. Pacific Time.
  • Poster Number 146: Open-Label Study of Pimavanserin in Patients With Comorbid Parkinson's Disease and Depression presented on October 4, 2019, 1:30 – 3:00 p.m. Pacific Time.
  • Poster Number 147: A Post Hoc Analysis Evaluating the Impact of a Reduction in Psychosis on the Severity of Agitation and Aggression in Patients With Alzheimer's Disease presented on October 4, 2019, 1:30 – 3:00 p.m. Pacific Time.
  • Poster Number 211: CLARITY: A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder presented on October 4, 2019, 1:30 – 3:00 p.m. Pacific Time.

About 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 psychosis, schizophrenia, depression, and other neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. ACADIA is evaluating pimavanserin in an extensive clinical development program across multiple indications with significant unmet need including dementia-related psychosis, adjunctive major depressive disorder, and the negative symptoms of schizophrenia. 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®. NUPLAZID is not approved for dementia-related psychosis, schizophrenia or major depressive disorder.

About ACADIA Pharmaceuticals

ACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. ACADIA also has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, schizophrenia, major depressive disorder, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include, but are not limited to, statements related to: the potential benefits of pimavanserin for central nervous system disorders as well as the potential results of clinical trials of pimavanserin in other indications. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2018 as well as ACADIA's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

Important Safety Information and Indication for NUPLAZID (pimavanserin)

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-related psychosis unrelated to the hallucinations and delusions associated with Parkinson's disease psychosis.
  • 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.
  • 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 including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain 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 most common 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 (e.g., ketoconazole) 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.

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

Dosage and Administration: Recommended dose: 34 mg capsule taken orally once daily, without titration.

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

Please see the full Prescribing Information including Boxed WARNING for NUPLAZID.

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