“On behalf of the entire management team, I want to thank Todd for hismany contributions to the Company and the finance function during animportant period in ACADIA’s growth and wish him all the best in hisfuture endeavors,” said
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development andcommercialization of innovative medicines to address unmet medical needsin central nervous system disorders. ACADIA has developed and iscommercializing the first and only medicine approved for the treatmentof hallucinations and delusions associated with Parkinson’s diseasepsychosis. In addition, ACADIA has ongoing clinical development effortsin additional areas with significant unmet need, includingdementia-related psychosis, schizophrenia inadequate response,schizophrenia-negative symptoms, major depressive disorder and Rettsyndrome. This press release and further information about ACADIA can befound at: www.acadia-pharm.com.
About NUPLAZID® (pimavanserin)
NUPLAZID is the first FDA-approved treatment for hallucinations anddelusions associated with Parkinson’s disease psychosis. NUPLAZID is anon-dopaminergic, selective serotonin inverse agonist preferentiallytargeting 5-HT2A receptors that are thought to play animportant role in Parkinson’s disease psychosis. NUPLAZID is an oralmedicine taken once a day with a recommended dose of 34 mg. ACADIAdiscovered and developed this new chemical entity and holds worldwiderights to develop and commercialize NUPLAZID.
Forward-Looking Statements
Statements in this press release that are not strictly historical innature are forward-looking statements. These statements include but arenot limited to statements regarding the timing of future events. Thesestatements are only predictions based on current information andexpectations and involve a number of risks and uncertainties. Actualevents or results may differ materially from those projected in any ofsuch statements due to various factors, including the uncertainty offuture commercial sales and related items that would impact net salesduring 2018, the risks and uncertainties inherent in drug discovery,development, approval and commercialization, and the fact that pastresults of clinical trials may not be indicative of future trialresults. For a discussion of these and other factors, please refer toACADIA’s annual report on Form 10-K for the year ended
Important Safety Information and Indication forNUPLAZID (pimavanserin)
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITHDEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated withantipsychotic drugs are at an increased risk of death. NUPLAZID is notapproved for the treatment of patients with dementia-related psychosisunrelated to the hallucinations and delusions associated withParkinson’s disease psychosis.
NUPLAZID is an atypical antipsychotic indicated for the treatment ofhallucinations and delusions associated with Parkinson’s diseasepsychosis.
Contraindication: NUPLAZID is contraindicated in patients with a historyof a hypersensitivity reaction to pimavanserin or any of its components.Rash, urticaria, and reactions consistent with angioedema (e.g., tongueswelling, circumoral edema, throat tightness, and dyspnea) have beenreported.
QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use ofNUPLAZID should be avoided in patients with known QT prolongation or incombination with other drugs known to prolong QT interval includingClass 1A antiarrhythmics or Class 3 antiarrhythmics, certainantipsychotic medications, and certain antibiotics. NUPLAZID should alsobe avoided in patients with a history of cardiac arrhythmias, as well asother circumstances that may increase the risk of the occurrence oftorsade de pointes and/or sudden death, including symptomaticbradycardia, hypokalemia or hypomagnesemia, and presence of congenitalprolongation of the QT interval.
Adverse Reactions: The most common adverse reactions (≥2% for NUPLAZIDand 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 mgtaken orally as one tablet once daily. Coadministration with strongCYP3A4 inducers may reduce NUPLAZID exposure. Monitor patients forreduced efficacy and an increase in NUPLAZID dosage may be needed.
Pediatric Use: Safety and efficacy have not been established inpediatric patients.
Dosage and Administration: Recommended dose: 34 mg taken orally oncedaily, without titration.
NUPLAZID is available as 34 mg capsules, 17 mg tablets and 10 mg tablets.
For additional Important Safety Information, including Boxed WARNING,please see the full Prescribing Information for NUPLAZID at https://www.nuplazid.com/pdf/NUPLAZID_Prescribing_Information.pdf.
Source:
Investor Contact:
ACADIA Pharmaceuticals Inc.
ElenaRidloff, CFA
(858) 558-2871
ir@acadia-pharm.com
or
MediaContact:
ACADIA Pharmaceuticals Inc.
Maurissa Messier
(858)558-2871
media@acadia-pharm.com