Acadia Pharmaceuticals Announces Outcome of FDA Advisory Committee for NUPLAZID® (pimavanserin) for the Treatment of Alzheimer’s Disease Psychosis

Rhea-AI Summary

Acadia Pharmaceuticals (NASDAQ: ACAD) announced that the FDA Psychopharmacologic Drugs Advisory Committee voted 9 to 3 against the efficacy of pimavanserin for treating hallucinations and delusions in Alzheimer’s disease psychosis (ADP). CEO Steve Davis expressed disappointment but noted the company's belief in the drug's substantial efficacy based on multiple clinical studies. The FDA, although not bound by the committee's recommendation, will consider the vote as it reviews the full safety and efficacy data, with a target action date set for August 4, 2022.

Positive

• CEO believes in substantial evidence supporting pimavanserin's efficacy in ADP.
• Pimavanserin is already an approved treatment for Parkinson's disease psychosis.

Negative

• PDAC voted 9 to 3 against pimavanserin's efficacy for ADP.
• The lack of FDA approval for pimavanserin in treating ADP could hinder market potential.

SAN DIEGO--(BUSINESS WIRE)-- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced the outcome of the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) meeting for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). The PDAC voted 9 to 3 that the evidence presented does not support a conclusion that pimavanserin is effective for the treatment of hallucinations and delusions in the ADP population.

“We are disappointed with the outcome of today’s vote. We will continue to work closely with the FDA as it completes its review of the totality of our efficacy and safety data to enable a full assessment of pimavanserin’s benefit-risk in patients with ADP,” said Steve Davis, Chief Executive Officer. “We continue to believe there is substantial evidence across multiple independent clinical studies and endpoints that support the efficacy of pimavanserin in ADP. There are no FDA approved treatments for this critical public health need and off-label use of multi-receptor acting antipsychotics have demonstrated poor patient outcomes, including worsening of cognition and motor function.”

The FDA asked the PDAC today for advice and recommendations regarding the evidence that pimavanserin is effective for the treatment of hallucinations and delusions associated with ADP. The FDA is not bound by the PDAC’s recommendations, but takes its advice into consideration when making decisions on drug applications. The FDA’s target action date is August 4, 2022.

NUPLAZID was approved in the U.S. in 2016 as the first and only treatment for hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). The totality of clinical trial, post-marketing and observational real-world evidence continue to support a positive benefit-risk profile for NUPLAZID for the treatment of hallucinations and delusions associated with PDP.

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.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. Alzheimer’s 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 was the outcome of the PDAC meeting regarding ACAD's pimavanserin?

The PDAC voted 9 to 3 against the efficacy of pimavanserin for treating hallucinations and delusions in Alzheimer's disease psychosis.

What does the FDA's target action date signify for ACAD?

The FDA's target action date for its review of pimavanserin is August 4, 2022.

What is ACAD's stance on pimavanserin's efficacy after the PDAC vote?

ACAD continues to believe that there is substantial evidence supporting pimavanserin's efficacy in treating Alzheimer's disease psychosis.

Is pimavanserin approved for any conditions?

Yes, pimavanserin (trade name NUPLAZID) is approved for treating hallucinations and delusions associated with Parkinson's disease psychosis.

What implications does the PDAC vote have for ACAD's stock?

The unfavorable PDAC vote may impact investor confidence and could lead to stock price volatility for ACAD.