Acadia Pharmaceuticals Announces Resubmission of Supplemental New Drug Application to U.S. FDA for NUPLAZID® (pimavanserin) to Treat Alzheimer’s Disease Psychosis

Rhea-AI Summary

Acadia Pharmaceuticals (NASDAQ: ACAD) has resubmitted its supplemental New Drug Application (sNDA) for pimavanserin to the FDA, addressing the issues raised in a Complete Response Letter received in April 2021. The sNDA is aimed at gaining approval for pimavanserin to treat hallucinations and delusions associated with Alzheimer's disease psychosis (ADP). The resubmission includes new analyses from the HARMONY and Study-019 clinical trials, which support the proposed indication. Currently, no FDA-approved treatment exists for ADP.

Positive

• Resubmission of the sNDA indicates ongoing commitment to addressing ADP treatment.
• Inclusion of additional clinical study analyses may strengthen the application.
• Potential expansion of the market for pimavanserin if approved for ADP.

Negative

• Previous Complete Response Letter indicates regulatory challenges.
• Uncertainty remains regarding FDA approval timeline and outcome.

SAN DIEGO--(BUSINESS WIRE)-- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced today that it has resubmitted its supplemental New Drug Application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP) to the U.S. Food and Drug Administration (FDA).

This resubmission is in response to the FDA’s April 2, 2021 Complete Response Letter (CRL) to the sNDA originally submitted for a proposed indication for pimavanserin for the treatment of dementia-related psychosis. The resubmission provides additional analyses from two previously conducted clinical studies, HARMONY¹ and Study -019², to support a proposed indication for the treatment of ADP and is intended to address the issues raised in the FDA’s CRL.

About Alzheimer’s Disease Psychosis
According to the Alzheimer’s Association, over six million people in the United States are living with Alzheimer’s disease³ (AD). Approximately 30% of patients with AD experience psychosis, commonly consisting of hallucinations and delusions⁴. These symptoms may be frequent and severe and may recur over time. A hallucination is defined as a perception-like experience that occurs without an external stimulus and is sensory (seen, heard, felt, tasted, sensed) in nature. A delusion is defined as a false, fixed belief that is resolutely held despite evidence to the contrary. Serious consequences have been associated with psychosis in patients with dementia, such as repeated hospital admissions, increased likelihood of nursing home placement, faster progression of dementia, and increased risk of morbidity and mortality⁵. There is no FDA approved drug for the treatment of Alzheimer’s disease psychosis.

About Pimavanserin
Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT_2A 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^®. NUPLAZID is not approved for Alzheimer’s disease psychosis. In addition, Acadia is developing pimavanserin in other neuropsychiatric conditions.

About Acadia Pharmaceuticals
Acadia is advancing breakthroughs in neuroscience to elevate life. For more than 25 years we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only approved therapy for hallucinations and delusions associated with Parkinson’s disease psychosis. Our late-stage development efforts are focused on treating psychosis in patients with dementia, the negative symptoms of schizophrenia and Rett syndrome. Our early-stage development efforts are focused on novel approaches to pain management, cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn and Twitter.

Important Safety Information and Indication for NUPLAZID^® (pimavanserin)

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-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.

• 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 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 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.

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 read the full Prescribing Information including Boxed WARNING.

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 regarding the timing of future events. 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. 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, 2020 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.

References
¹Tariot PN, et al. N Engl J Med. 2021; 385(4):309-319.
²Ballard C, et al. Lancet Neurol. 2018;17(3):213-222. Ballard C, et al. J Prev Alzheimers Dis. 2019;6(1):27-33.
³2021 Alzheimer’s Disease Facts and Figures and Rajan KB, et al. Alzheimer’s Dement. 2021;17(12):1966-1975.
⁴Cummings J, et al. Am J Geriatr Psychiatry 2020;28(12):1256-1269.
⁵Connors MH et al. Am J Geriatr Psychiatry 2018;26(3). Peters ME et al. Am J Psychiatry 2015;172(5). Haupt M et al. Int J Geriatr Psychiatry 1996;11(11). Naimark D et al. J Am Geriatr Soc 1996;44(3). Stern Y et al. Neurology 1994;44(12).

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Media Contact:

Acadia Pharmaceuticals Inc.

Deb Kazenelson

(818) 395-3043

media@acadia-pharm.com

Investor Contact:

Acadia Pharmaceuticals Inc.

Mark Johnson, CFA

(858) 261-2771

ir@acadia-pharm.com

Source: Acadia Pharmaceuticals Inc.

FAQ

What is the recent news about Acadia Pharmaceuticals (ACAD)?

Acadia Pharmaceuticals has resubmitted its supplemental New Drug Application (sNDA) for pimavanserin to the FDA for treating hallucinations and delusions associated with Alzheimer's disease psychosis.

What does the Complete Response Letter mean for ACAD?

The Complete Response Letter received in April 2021 signifies that the FDA had concerns with the initial sNDA submission, requiring additional information for approval.

What clinical studies were included in ACAD's sNDA resubmission?

The resubmission includes analyses from the HARMONY study and Study-019, aimed at supporting the proposed indication for pimavanserin.

What is pimavanserin approved for currently?

Pimavanserin is currently FDA-approved for treating hallucinations and delusions associated with Parkinson's disease psychosis.

What is the potential market for pimavanserin if approved for Alzheimer's disease psychosis?

If approved for Alzheimer's disease psychosis, pimavanserin could address a significant unmet need in treating hallucinations and delusions in Alzheimer's patients.