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Acadia Pharmaceuticals Provides Regulatory Update on Supplemental New Drug Application for Pimavanserin for the Treatment of Hallucinations and Delusions Associated with Dementia-Related Psychosis - Conference call and w

Key Takeaway: Acadia Pharmaceuticals Provides Regulatory Update on Supplemental New Drug Application for Pimavanserin for the Treatment of Hallucinations and Delusions Associated with Dementia-Related Psychosis - Conference call and webcast to be held today at 5:00 p.m. Eastern Time SAN DI

Full Press Release Details

Acadia Pharmaceuticals Provides Regulatory Update on
Supplemental New Drug Application for Pimavanserin for the Treatment of
Hallucinations and Delusions Associated with Dementia-Related Psychosis
- Conference call and webcast to be held today at 5:00 p.m. Eastern Time
SAN DIEGO March 8, 2021 Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the Company received a notification
from the U.S. Food and Drug Administration (FDA) on March 3, 2021, stating that, as part of its ongoing review of the Company s supplemental New Drug Application (sNDA), the FDA has identified deficiencies that preclude discussion of
labeling and post-marketing requirements/commitments at this time. The FDA stated that the notification does not reflect a final decision on the information under review.
The notification does not specify the deficiencies identified by the FDA and there has been no clarification by the FDA at this time. The Company plans to
work with the FDA to learn the nature of the deficiencies and seek to resolve them. In July 2020, the FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of April 3, 2021 for completion of its review of the sNDA.
Conference Call and Webcast Information
management will discuss today s announcement via conference call and webcast at 5:00 p.m. Eastern Time. 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 4153316). A telephone replay of the conference call may be
accessed through March 15, 2021 by dialing 855-859-2056 for callers in the United States or Canada and 404-537-3406 for international callers (reference passcode 4153316). 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 through April 8, 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
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)
NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinson s disease psychosis.
Important Safety Information
MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED 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 read the full Prescribing Information including Boxed WARNING.
Acadia Pharmaceuticals Inc.
Acadia Pharmaceuticals Inc.
Last updated: Mar 8, 2021