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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 maintains a website at www.acadia-pharm.com towhich we regularly post copies of our press releases as well asadditional information and through which interested parties cansubscribe to receive e-mail alerts.
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 related to the benefits to be derived fromACADIA’s commercial products and development compounds, includingNUPLAZID. These statements are only predictions based on currentinformation and expectations and involve a number of risks anduncertainties. Actual events or results may differ materially from thoseprojected in any of such statements due to various factors, includingthe risks and uncertainties inherent in drug discovery, development, andcommercialization, and the fact that past results of clinical trials maynot be indicative of future trial results. For a discussion of these andother factors, please refer to ACADIA’s annual report on Form 10-K forthe year ended
Important Safety Information and Indication forNUPLAZID (pimavanserin) tablets
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 hypersensitivity reaction to pimavanserin or any of its components.Reactions have included rash, urticaria, tongue swelling, circumoraledema, and throat tightness.
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 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: Strong CYP3A4 inhibitors (eg, ketoconazole)increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half.Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reducedefficacy. Increase in NUPLAZID dosage may be needed.
Renal Impairment: No dosage adjustment for NUPLAZID is needed inpatients with mild to moderate renal impairment. Use of NUPLAZID is notrecommended in patients with severe renal impairment.
Hepatic Impairment: Use of NUPLAZID is not recommended in patients withhepatic impairment. NUPLAZID has not been evaluated in this patientpopulation.
Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated andshould therefore be used in pregnancy only if the potential benefitjustifies the potential risk to the mother and fetus.
Pediatric Use: Safety and efficacy have not been established inpediatric patients.
Dosage and Administration: Recommended dose: 34 mg per day, taken orallyas two 17-mg tablets once daily, without titration.
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.
LisaBarthelemy
(858) 558-2871
ir@acadia-pharm.com
or
MediaContact:
Taft Communications
Bob Laverty
(609)558-5570
bob@taftcommunications.com