ACAD ACADIA Pharmaceuticals Inc.

21.63
-0.66  -3%
Previous Close 22.29
Open 22.13
52 Week Low 19.2
52 Week High 57.46
Market Cap $3,464,672,549
Shares 160,179,036
Float 98,680,233
Enterprise Value $2,953,567,548
Volume 1,088,761
Av. Daily Volume 1,705,699
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Upcoming Catalysts

Drug Stage Catalyst Date
Trofinetide (LAVENDER)
Rett Syndrome
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
ACP-044
Pain
Phase 2
Phase 2
Phase 2 trial initiated March 2021.
NUPLAZID (pimavanserin) CLARITY-2 and CLARITY-3
Adjunctive Treatment in Patients With Major Depressive Disorder
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - July 20, 2020.
NUPLAZID (pimavanserin) Advance-2
Adjunctive treatment in patients with negative symptoms of schizophrenia
Phase 3
Phase 3
Phase 3 trial initiated 3Q 2020.
NUPLAZID (pimavanserin) Enhance
Adjunctive treatment of schizophrenia
Phase 3
Phase 3
Phase 3 data did not meet primary endpoint - July 22, 2019.
NUPLAZID (pimavanserin)
Alzheimer’s disease psychosis
CRL
CRL
CRL announced April 5, 2021.
NUPLAZID (pimavanserin)
Parkinson’s disease psychosis (PDP)
Approved
Approved
Approved April 29 2016. Additional dose approval announced June 29, 2018.

Latest News

  1. - Pimavanserin met the primary endpoint of reduced risk of relapse of psychosis by 2.8 fold compared to placebo

    - Pimavanserin met the secondary endpoint of significantly reducing trial discontinuation for any reason by 2.2 fold

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) announced today that the New England Journal of Medicine published results from the Phase 3 HARMONY study, an international, double-blind, placebo-controlled relapse prevention trial in 392 patients evaluating pimavanserin as an investigational treatment in patients with hallucinations and delusions associated with dementia-related psychosis (DRP). The study included patients across five subgroups of dementia: Alzheimer's disease, dementia with Lewy bodies, frontotemporal…

    - Pimavanserin met the primary endpoint of reduced risk of relapse of psychosis by 2.8 fold compared to placebo

    - Pimavanserin met the secondary endpoint of significantly reducing trial discontinuation for any reason by 2.2 fold

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) announced today that the New England Journal of Medicine published results from the Phase 3 HARMONY study, an international, double-blind, placebo-controlled relapse prevention trial in 392 patients evaluating pimavanserin as an investigational treatment in patients with hallucinations and delusions associated with dementia-related psychosis (DRP). The study included patients across five subgroups of dementia: Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia, Parkinson's disease dementia, and vascular dementia.

    The HARMONY study was stopped early due to positive efficacy at the pre-planned interim analysis upon recommendation of the trial's independent data safety monitoring board. HARMONY met its primary endpoint by significantly reducing the risk of relapse of psychosis by 2.8 fold compared to placebo in the double-blind period (hazard ratio (HR)=0.35, two-sided p=0.005; one-sided p=0.0023). The study also met its secondary endpoint by significantly reducing the time to trial discontinuation for any reason (HR=0.45, two-sided p=0.005; one-sided p=0.0024). The data from the HARMONY study demonstrates that patients with DRP who had responded to pimavanserin had a significantly lower risk of relapse of psychosis with continuation of pimavanserin compared to placebo up to 26 weeks.

    "The relapse prevention design of the HARMONY study mirrors exactly what we do in clinical practice. This landmark trial showed that when patients responded to pimavanserin and then continued treatment, they were almost three times less likely to develop recurrence of their hallucinations and delusions than those patients who discontinued pimavanserin treatment," said the study's lead author, Dr. Pierre N. Tariot, Banner Alzheimer's Institute director. "This is a substantial finding and a significant advance for a critical public health need in our field. There is no FDA approved treatment for DRP, and the majority of antipsychotics currently used off-label have equivocal efficacy and may accelerate cognitive decline."

    Pimavanserin was well-tolerated over the nine-month study duration. In a pre-specified analysis, pimavanserin was not associated with a decline in cognition as measured by Mini-Mental State Examination (MMSE) or the onset or worsening of motor symptoms as measured by Extrapyramidal Symptom Rating Scale A (ESRS-A).

    "The HARMONY study findings demonstrated three important results. First, in the 12-week open-label period, pimavanserin treatment showed a sustained reduction of psychotic symptoms. Second, in the 26-week double-blind period, patients on pimavanserin had a nearly three-fold reduction of risk of psychosis relapse compared to patients on placebo. Third, pimavanserin was well-tolerated by elderly patients with DRP," said Steve Davis, Chief Executive Officer of Acadia. "We are very pleased that the New England Journal of Medicine has chosen to publish the important results of this study."

    About HARMONY

    HARMONY was a Phase 3 study designed to evaluate the efficacy and safety of pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis. The study included patients with Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia, Parkinson's disease dementia, and vascular dementia. A total of 392 patients were enrolled in the study, with a mean age of 74.5 years and a mean MMSE score of 16.7. The primary endpoint in the study was time from randomization to relapse of psychosis in the double-blind period as represented by the Kaplan-Meier curve and the hazard ratio.

    The HARMONY study included a 12-week, open-label stabilization period during which patients with dementia-related psychosis began treatment with pimavanserin 34 mg once daily. In the open-label period, a majority (61.8%) of eligible subjects (n=351) met the sustained treatment response criteria at Week 8 and Week 12 and entered the double-blind period. Following the open-label period, patients who met pre-specified criteria for sustained treatment response were then randomized into the double-blind period of the study to continue their pimavanserin dose or switched to placebo and followed for up to 26 weeks or until a relapse of psychosis occurred. Pimavanserin met its primary endpoint and was stopped at the pre-planned interim analysis for positive efficacy, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo (HR=0.35, p=0.005).

    In the double-blind period, similar, low rates of adverse events were observed, 43 (41.0%) patients on pimavanserin (n=105) and 41 (36.6%) patients on placebo (n=112). Discontinuations in the double-blind period due to adverse events were low, 2.9% for pimavanserin and 3.6% for placebo. Rates of serious adverse events were also low, 4.8% in the pimavanserin group and 3.6% in the placebo group. One death was reported in the open-label period and one death was reported in the pimavanserin group during the double-blind period. Investigators determined that neither death was related to the study drug.

    About Dementia-Related Psychosis

    Approximately 8 million people in the United States are living with dementia, a condition with a core feature of declining cognition (changes in memory, decision-making abilities, language, etc.) resulting in functional impairment. Dementia is a manifestation of an underlying condition which is often progressive and neurodegenerative in nature.1 In addition to cognitive decline, dementing illnesses almost universally lead to neuropsychiatric symptoms, which may include hallucinations, delusions, and changes in behavior.

    It is estimated that 2.4 million Americans (or 30% of people with dementia) experience dementia-related hallucinations and delusions.2,3 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. Dementia-related psychosis occurs in many types of dementia, including Alzheimer's disease, dementia with Lewy bodies, Parkinson's disease dementia, vascular dementia, and frontotemporal dementia. 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 mortality.4

    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 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 dementia-related psychosis. In addition, Acadia is developing pimavanserin in other neuropsychiatric conditions.

    About Acadia Pharmaceuticals

    Acadia is trailblazing 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 dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and 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.

    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.

    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.

    References

    1Dementia. (2019, September 19). Retrieved from https://www.who.int/news-room/fact-sheets/detail/dementia.

    2Plassman BL, et al. Prevalence of dementia in the United States: The Aging Demographics, and Memory study. Neuroepidemiology. 2007;29(1-2):125-132.

    32017 Alzheimer's Disease Facts and Figures and Acadia market research.

    4Connors 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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  2. Company to host conference call and webcast on Wednesday, August 4, 2021, at 4:30 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report second quarter 2021 financial results on Wednesday, August 4, 2021, after the close of the U.S. financial markets. Acadia's management team will also host a conference call and webcast on August 4, 2021, at 4:30 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 8065926). A telephone replay of the conference call may be accessed through August 18, 2021 by dialing 855-859-2056 for callers…

    Company to host conference call and webcast on Wednesday, August 4, 2021, at 4:30 p.m. Eastern Time

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will report second quarter 2021 financial results on Wednesday, August 4, 2021, after the close of the U.S. financial markets. Acadia's management team will also host a conference call and webcast on August 4, 2021, at 4:30 p.m. Eastern Time to discuss financial results and operations.

    The conference call may be accessed by dialing 855-638-4820 for participants in the United States or Canada and 443-877-4067 for international callers (reference passcode 8065926). A telephone replay of the conference call may be accessed through August 18, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 8065926). The conference call also will be webcast live on Acadia's website, www.acadia-pharm.com under the investors section and will be archived there until September 1, 2021.

    About Acadia Pharmaceuticals

    Acadia is trailblazing 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 dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and 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.

    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.

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  3. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that three scientific presentations in dementia-related psychosis (DRP) will be shared at the Alzheimer's Association International Conference® 2021 (AAIC®), being held July 26-30, 2021 in Denver, Colo., and virtually.

    The poster presentations include two analyses of patients who have neurodegenerative disease taking pimavanserin while also receiving other antidementia medication. One presentation focuses on safety outcomes while the second describes the impact of an acetylcholinesterase inhibitor (AChEI) on the pharmacokinetic profile of pimavanserin in patients with dementia-related psychosis. The third presentation will discuss a novel screening tool for psychosis in dementia patients…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that three scientific presentations in dementia-related psychosis (DRP) will be shared at the Alzheimer's Association International Conference® 2021 (AAIC®), being held July 26-30, 2021 in Denver, Colo., and virtually.

    The poster presentations include two analyses of patients who have neurodegenerative disease taking pimavanserin while also receiving other antidementia medication. One presentation focuses on safety outcomes while the second describes the impact of an acetylcholinesterase inhibitor (AChEI) on the pharmacokinetic profile of pimavanserin in patients with dementia-related psychosis. The third presentation will discuss a novel screening tool for psychosis in dementia patients.

    AAIC Accepted Presentations:

    • Poster Presentation (#57661): Pimavanserin and concomitant antidementia medication use in patients with neurodegenerative and/or neurovascular disorders: safety outcomes from pooled clinical data and the HARMONY study, available to view starting Monday, July 26.

      Presenting Author: George Demos, M.D., Acadia Pharmaceuticals Inc.
    • Poster Presentation (#57479): Impact of concomitant acetylcholinesterase inhibitor use on the pharmacokinetic profile of pimavanserin in patients with dementia-related psychosis: modeling data from the Phase 3 HARMONY study, available to view starting Monday, July 26.

      Presenting Author: Mona Darwish, Ph.D., Acadia Pharmaceuticals Inc.
    • Poster Presentation (#57766): Development and Assessment of a Brief Screening Tool for Psychosis in Dementia, available to view starting Monday, July 26

      Presenting Author: Jeffrey Cummings, M.D., Sc.D., Joy Chambers-Grundy Professor of Brain Science, Vice Chair for Research, and Director of the Chambers-Gundy Center for Transformative Neuroscience, Department of Brain Health, School of Integrated Health Sciences, University of Nevada Las Vegas (UNLV).

    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 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 dementia-related psychosis. In addition, Acadia is developing pimavanserin in other neuropsychiatric conditions.

    About Acadia Pharmaceuticals

    Acadia is trailblazing 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 dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and 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.

    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.

    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.

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  4. - Patients previously treated with 34 mg showed sustained response

    - Patients on investigational doses and placebo demonstrated symptom improvement when switched to 34 mg dose during OLE

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced publication of open-label extension (OLE) data from patients experiencing hallucinations and delusions associated with Parkinson's disease psychosis (PDP) who had previously completed one of three, six-week, double-blind, placebo-controlled studies.

    The OLE efficacy analysis showed that patients previously on NUPLAZID 34 mg had a sustained efficacy response from Week 6 through Week 10, and that patients who had been treated with investigational doses of 8.5 mg and 17 mg or placebo also showed an improvement…

    - Patients previously treated with 34 mg showed sustained response

    - Patients on investigational doses and placebo demonstrated symptom improvement when switched to 34 mg dose during OLE

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced publication of open-label extension (OLE) data from patients experiencing hallucinations and delusions associated with Parkinson's disease psychosis (PDP) who had previously completed one of three, six-week, double-blind, placebo-controlled studies.

    The OLE efficacy analysis showed that patients previously on NUPLAZID 34 mg had a sustained efficacy response from Week 6 through Week 10, and that patients who had been treated with investigational doses of 8.5 mg and 17 mg or placebo also showed an improvement in the symptoms of psychosis when switched to NUPLAZID 34 mg over the 4 weeks of the OLE. The completed study was published online and in the June issue of Parkinsonism and Related Disorders. Full text of the paper can be found at: https://www.prdjournal.com/article/S1353-8020(21)00145-0/fulltext.

    "Results from a multi-center OLE study, across 14 countries, demonstrate the extended durability of efficacy of NUPLAZID for treating hallucinations and delusions associated with PDP, in addition to reinforcing the efficacy seen in the original pivotal trial using the 34 mg dose," said Stuart Isaacson, M.D., Director, Parkinson's Disease and Movement Disorders Center of Boca Raton. "As a physician, having NUPLAZID, an FDA-approved and proven therapy to treat these debilitating symptoms without impairing motor function, represents a major step forward. NUPLAZID is a critical first-line therapy for our patients living with PDP, and their caregivers."

    Importantly, non-motor symptoms of Parkinson's disease, including hallucinations and delusions, can be more troublesome than motor symptoms.1 Hallucinations and delusions can also worsen over time, making it difficult for patients to know whether or not what they are experiencing is real.2,3

    "We're pleased to have additional published data supporting the efficacy of NUPLAZID, as approximately 50 percent of people living with Parkinson's may experience hallucinations and delusions during the course of their disease," said Ponni Subbiah, M.D., M.P.H., Senior Vice President, Global Head of Medical Affairs and Chief Medical Officer at Acadia. "These symptoms can have a significant impact on both patients and their families, negatively impacting their quality of life and causing severe emotional distress."

    About the Open-Label Extension (OLE) Study

    The OLE study was designed to evaluate the long-term safety of NUPLAZID. The publication includes an analysis of the efficacy results from the initial four weeks of the OLE study and included patients who had previously completed one of three, six-week, double-blind, placebo-controlled studies. All patients in the OLE were treated with NUPLAZID 34 mg. Changes in PDP symptoms were evaluated according to the Scale for the Assessment of Positive Symptoms (SAPS): the SAPS-PD and the Hallucinations + Delusions domains, Clinical Global Impression (CGI) Improvement and Severity scales and Caregiver Burden Scale (CBS).

    Of 459 patients enrolled in the OLE, 424 (92.4%) had a Week 4 efficacy assessment. Overall, the response to NUPLAZID 34 mg that was observed in the SAPS-PD scores during the initial six weeks persisted through Week 4 of the OLE (mean change from OLE baseline (standard deviation) to OLE Week 4 for the SAPS-PD of -0.8 (5.6)), while scores among patients switched from placebo to NUPLAZID 34 mg improved (with a mean change from OLE baseline to OLE Week 4 in the SAPS-PD of -2.9 (5.6)). For patients treated with pimavanserin 8.5 mg or 17 mg investigational doses in the previous studies, further improvement was observed during the OLE with NUPLAZID 34 mg.

    During the initial four weeks of the OLE study, adverse events (AEs) were reported by 215 (46.8%) patients. Twenty-seven (5.9%) patients had an AE that resulted in discontinuation of the study or study drug. The majority of AEs were of mild or moderate intensity; seven (1.5%) patients had serious AEs. The most common AEs were fall (5.9%), hallucination (3.7%), urinary tract infection (2.8%), insomnia (2.4%), and peripheral edema (2.2%). Complete safety findings from the OLE study over 9 years of study follow-up were previously published by Ballard CG, et al.4

    About Parkinson's Disease and Parkinson's Disease Psychosis

    Parkinson's disease is a progressive nervous system disorder that affects about one million people in the United States.5,6 The signs and symptoms can vary with people experiencing both motor symptoms and non-motor symptoms such as hallucinations (seeing, hearing, or experiencing things that others don't) and delusions (false beliefs).3,7 Physicians may refer to these Parkinson's-related hallucinations and delusions as Parkinson's disease psychosis (PDP).3 Around 50 percent of people living with Parkinson's may experience hallucinations or delusions during the course of their disease.7 Non-motor symptoms, as a whole, can be more troublesome than motor symptoms, in terms of quality of life.1 PDP may add to the burden of caring for a loved one with Parkinson's disease.8,9

    About NUPLAZID® (pimavanserin)

    NUPLAZID 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. NUPLAZID is not approved for dementia-related psychosis. In addition, Acadia is developing pimavanserin in other neuropsychiatric conditions.

    About Acadia Pharmaceuticals

    Acadia is trailblazing 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 dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

    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.

    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.

    1 Martinez-Martin P, Rodriguez-Blazquez C, et al. The Impact of Non-Motor Symptoms on Health Related Quality of Life of Patients with Parkinson's Disease. Mov Disord. 2011;26(3):399-406.

    2 Goetz, CG, Fan, W, Leurgans, S, et al. The malignant course of "benign hallucinations" in Parkinson disease. Archives of neurology. 2006;63(5), 713–716

    3 Ravina B, Marder K, Fernandez HH, et al. Diagnostic criteria for psychosis in Parkinson's disease: report of an NINDS, NIMH work group. Mov Disord. 2007 Jun 15;22(8):1061-8.

    4 Ballard CG, Kreitzman DL, Isaacson S, et al. Long-term evaluation of open-label pimavanserin safety and tolerability in Parkinson's disease psychosis. Parkinsonism Relat Disord. 2020;77:100-106.

    5 Parkinson's Disease Foundation. What is Parkinson's disease? Retrieved from https://www.pdf.org/en/about_pd. Accessed November 2014.

    6 Postuma, RB, et al. MDS Clinical Diagnostic Criteria for Parkinson's Disease. Mov Disorders. 2015; 30(12): 1591-1599

    7 Forsaa EB, Larsen JP, Wentzel-Larsen T, et al. A 12-year population-based study of psychosis in Parkinson's disease. Arch Neurol. 2010;67:996-1001.

    8 Schrag A, Hovris A, et al. Caregiver-burden in parkinson's disease is closely associated with psychiatric symptoms, falls, and disability. Parkonism and Related Disorders. 2006;12:35-41

    9 Aarsland D, Bronnick K, Ehrt U. et al. Neuropsychiatric symptoms in patients with Parkinson's disease and dementia: frequency, profile and associated care giver stress. J Neurol Neurosurg Psychiatry. 2007;78:36-42.

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  5. Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following investor conferences:

    Jefferies 2021 Virtual Healthcare Conference
    Fireside Chat Presentation: Wednesday, June 2, 2021 at 1:30 p.m. Eastern Time

    Goldman Sachs 42nd Annual Global Healthcare Conference
    Fireside Chat Presentation: Tuesday, June 8, 2021 at 2:10 p.m. Eastern Time

    These conferences will be held virtually. Live webcasts of the presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

    About Acadia Pharmaceuticals

    Acadia is trailblazing breakthroughs in neuroscience…

    Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) today announced that it will participate at the following investor conferences:

    Jefferies 2021 Virtual Healthcare Conference

    Fireside Chat Presentation: Wednesday, June 2, 2021 at 1:30 p.m. Eastern Time

    Goldman Sachs 42nd Annual Global Healthcare Conference

    Fireside Chat Presentation: Tuesday, June 8, 2021 at 2:10 p.m. Eastern Time

    These conferences will be held virtually. Live webcasts of the presentations will be accessible on the company's website, www.acadia-pharm.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

    About Acadia Pharmaceuticals

    Acadia is trailblazing 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 dementia-related psychosis, negative symptoms of schizophrenia and Rett syndrome, and in early-stage clinical research we are exploring novel approaches to pain management, and cognition and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia-pharm.com and follow us on LinkedIn.

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