Acadia Pharmaceuticals Announces FDA Advisory Committee Meeting to Review Resubmission of Supplemental New Drug Application for NUPLAZID® (pimavanserin) for the Treatment of Alzheimer’s Disease Psychosis Scheduled for June 17, 2022

Rhea-AI Summary

Acadia Pharmaceuticals announced a virtual FDA meeting for the review of the supplemental New Drug Application (sNDA) for pimavanserin, aimed at treating hallucinations and delusions in Alzheimer’s disease psychosis. The meeting is set for June 17, 2022, with a target action date of August 4, 2022. CEO Steve Davis emphasized the urgency given the lack of FDA-approved treatments for this condition, which affects around 30% of the 6 million Alzheimer’s patients in the U.S. Pimavanserin is currently approved for Parkinson’s disease psychosis.

Positive

• Scheduled FDA Advisory Committee meeting on June 17, 2022, for pimavanserin sNDA.
• Potential to address a significant unmet medical need in Alzheimer's disease psychosis.
• Current approval of pimavanserin for Parkinson’s disease psychosis establishes a proven efficacy profile.

Negative

• No FDA-approved treatments for Alzheimer’s disease psychosis currently available.
• Risks associated with off-label use of antipsychotics, including worsening cognitive function.

SAN DIEGO--(BUSINESS WIRE)-- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that a virtual meeting of the U.S. Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee to review the resubmitted supplemental New Drug Application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP) has been scheduled for June 17, 2022. The target action date for the application is August 4, 2022.

“We appreciate our ongoing engagement with the FDA and look forward to a productive discussion on the clinical evidence supporting the positive benefit-risk profile for pimavanserin as a treatment for ADP at the upcoming Advisory Committee meeting,” said Steve Davis, Chief Executive Officer. “The hallucinations and delusions that Alzheimer’s patients endure represent one of the most significant burdens in this community, and one of the leading reasons for long-term care placement. There are no FDA-approved treatments for this critical public health need. Off-label use of multi-receptor acting antipsychotics with marginal efficacy and significant safety concerns can lead to poor patient outcomes, including worsening of cognition and motor function.”

About Alzheimer’s Disease Psychosis

According to the Alzheimer’s Association, approximately six million people in the United States are living with Alzheimer’s disease (AD).^1-2 Approximately 30% of patients with AD experience psychosis, commonly consisting of hallucinations and delusions.³ These symptoms may be frequent and severe and may recur over time. ⁴ A hallucination is defined as a perception-like experience that occurs without an external stimulus and is sensory (seen, heard, felt, tasted, sensed, smelled) in nature. A delusion is defined as a false, fixed belief despite evidence to the contrary. Serious consequences have been associated with psychosis in patients with dementia, such as increased likelihood of nursing home placement, more severe dementia, and increased risk of morbidity and mortality.^5-6 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, 2021 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

¹ Alzheimer’s Association. 2021 Alzheimer’s Disease Facts and Figures. Alzheimers Dement. 2021; 16(3): 391.
² Rajan, KB et al. Population estimate of people with clinical Alzheimer’s disease and mild cognitive impairment in the United States (2020-2060). Alzheimer’s and Dementia. 2021: 1-10.
³ Cummings J et al. Criteria for Psychosis in Major and Mild Neurocognitive Disorders: International Psychogeriatric Associations (IPA) Consensus Clinical and Research Definition. Am J of Geriatric Psychiatry. 2020; 28(12): 1256-1269.
⁴ Ballard C et al. A prospective study of psychotic symptoms in dementia sufferers: psychosis in dementia. Int Psychogeriatr. 1997; 9(1): 57-64.
⁵ Scarmeas N et al. Delusions and hallucinations are associated with worse outcome in Alzheimer Disease. Arch Neurol. 2005; 62(10): 1601-1608.
⁶ Peters ME et al. Neuropsychiatric symptoms as predictors of progression to severe Alzheimer’s dementia and death: the Cache County Dementia Progression study. Am J Psychiatry. 2015; 172(5): 460-465.

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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 purpose of the FDA meeting on June 17, 2022, regarding ACAD's pimavanserin?

The meeting will review the supplemental New Drug Application for pimavanserin as a treatment for hallucinations and delusions in Alzheimer’s disease psychosis.

What is the target action date for ACAD's sNDA for pimavanserin?

The target action date is August 4, 2022.

What percentage of Alzheimer's patients experience psychosis?

Approximately 30% of Alzheimer's patients experience psychosis, which includes hallucinations and delusions.

What is pimavanserin used for?

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

Why is there no FDA-approved treatment for Alzheimer’s disease psychosis?

Currently, there are no FDA-approved treatments specifically for Alzheimer’s disease psychosis, making pimavanserin a potential breakthrough.