The California Life Sciences Association’s (CLSA) DiNA Pantheon Awardsrecognize achievements and honor excellence in the life sciences sectorin
“We are honored to be recognized for our team’s hard work and commitmentto discovering, developing and commercializing NUPLAZID,” said
“We are pleased to honor this first-in-class, first-in-diseasemedication with this year’s Pantheon DiNA Award for OutstandingTherapeutic Product,” said
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 (two 17-mgtablets). ACADIA discovered this new chemical entity and holds worldwiderights to develop and commercialize NUPLAZID.
About Parkinson’s Disease Psychosis
According to the National Parkinson Foundation, about one million peoplein the
About California Life Sciences Association (CLSA)
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.comto which we regularly post copies of our press releases as well asadditional information and through which interested parties cansubscribe to receive email 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 progress and timing of ACADIA’sdrug discovery and development programs, and the benefits to be derivedfrom NUPLAZID™ (pimavanserin), including the promise or significance ofNUPLAZID and whether it will improve the lives of people withParkinson’s disease psychosis, and ACADIA’s product candidates. 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 risks anduncertainties inherent in drug discovery, development, approval andcommercialization, and in collaborations with others, and the fact thatpast results 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) tablets
WARNING: INCREASEDMORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderlypatients with dementia-related psychosis treated with antipsychoticdrugs are at an increased risk of death. NUPLAZID is not approved forthe treatment of patients with dementia-related psychosis unrelated tothe hallucinations and delusions associated with Parkinson’s diseasepsychosis.
NUPLAZID is an atypical antipsychotic indicated for the treatment ofhallucinations and delusions associated with Parkinson’s diseasepsychosis.
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 http://www.acadia-pharm.com/wp-content/uploads/2016/04/NUPLAZID-pimavanserin-Package-Insert.pdf.
Source:
Investor Contact:
ACADIA Pharmaceuticals Inc.
LisaBarthelemy, (858) 558-2871
ir@acadia-pharm.com
or
MediaContact:
Taft Communications
Ted Deutsch, (609)578-8765
ted@taftcommunications.com