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ACADIA Pharmaceuticals Supports Parkinson's Disease Awareness Month and World Parkinson's Day with Local Educational Initiatives and Community Events Across the Country

Business Wire 11-Apr-2019 9:00 AM

ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company focused on the development and commercialization of innovative medicines that address unmet medical needs in central nervous system disorders, today announced support of several educational events for the Parkinson's disease community and their caregivers. ACADIA is committed to supporting the Parkinson's community and increasing awareness about Parkinson's disease (PD) and Parkinson's disease psychosis (PDP), a progressive and debilitating non-motor condition characterized by hallucinations and delusions related to PD.

"We are driven to improve the lives of people with Parkinson's disease psychosis and their caregivers," said Steve Davis, ACADIA's Chief Executive Officer. "This April, in honor of Parkinson's Awareness Month and World Parkinson's Day, we encourage patients and their families to attend an event, which includes important resources to help them navigate their unique journey with Parkinson's. We are collaborating and pledging our support to Parkinson's patient advocacy organizations across the country to help make educational events possible year-round because we understand how critical this support and engagement can be for patients and their caregivers."

In addition to continued support for the Michael J. Fox Foundation (MJFF) Parkinson's Disease Education Consortium, an alliance between MJFF and industry partners committed to patient and caregiver knowledge through education programs, ACADIA is sponsoring several events and activities this Parkinson's Awareness Month, including:

"Moving Day walks are a critical component of the Parkinson's Foundation's efforts to raise money and help improve life for people affected by Parkinson's disease," said John Lehr, President and Chief Executive Officer of the Parkinson's Foundation. "We appreciate ACADIA's support to help make events including Moving Day possible. Funds raised through Moving Day help us deliver quality care, fund cutting-edge research, and provide free resources for people living with Parkinson's and their families. Since 2011, Moving Day events across the country have gathered more than 130,000 participants and raised nearly $22 million to improve care and advance research toward a cure."

About Parkinson's Disease and Parkinson's Disease PsychosisParkinson's disease is a progressive nervous system disorder. About one million people in the United States and from four to six million people worldwide suffer from Parkinson's disease. The signs and symptoms of Parkinson's can vary from person to person but generally fall into two types: motor and non-motor symptoms. Hallucinations (seeing, hearing, or experiencing things that others don't) and delusions (believing things that aren't true) are non-motor symptoms of Parkinson's disease. Together they are known as PDP and may affect around half of people living with PD over the course of their disease. People who develop non-motor symptoms of PD like hallucinations or delusions often have to deal with a broader set of challenges that can be more troublesome than motor symptoms in terms of quality of life. These non-motor symptoms may come with increased caregiver distress and burden and nursing home placement. More information about PDP is available at: www.Moretoparkinsons.com.

About ACADIA PharmaceuticalsACADIA is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. In addition, ACADIA has ongoing clinical development efforts in additional areas with significant unmet need, including dementia-related psychosis, schizophrenia inadequate response, schizophrenia-negative symptoms, major depressive disorder, and Rett syndrome. This press release and further information about ACADIA can be found at: www.acadia-pharm.com.

Important Safety Information and Indication for NUPLAZID (pimavanserin)

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.

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 most 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 CYP3A4 inducers may reduce NUPLAZID exposure. Monitor patients for reduced efficacy and an increase in NUPLAZID dosage may be needed.

Pediatric Use: Safety and efficacy have not been established in pediatric patients.

Dosage and Administration: Recommended dose: 34 mg taken orally once daily, without titration.

Indication: NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You can also call ACADIA Pharmaceuticals Inc. at 1-844-4ACADIA (1-844-422-2342).

NUPLAZID is available as 34 mg capsules and 10 mg tablets.

Please see the full Prescribing Information including Boxed WARNING for NUPLAZID at https://www.nuplazid.com/pdf/NUPLAZID_Prescribing_Information.pdf.

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