Two Independent Data Sets Confirm NUPLAZID Is Well-Tolerated andEfficacious in Treating Hallucinations and Delusions Associated withParkinson’s Disease Psychosis
Poster Presentations
Clinical Experience with Pimavanserin for Treatment of Parkinson’sDisease Psychosis
(Poster #040)
Researchers at
- >70% of all patients treated with NUPLAZID reported clinicalimprovement, while 88% of patients treated longer than four weeksimproved.
- 67% of patients have remained on NUPLAZID for an average of 10+ months.
- Only 11% of patients were unable to tolerate NUPLAZID due to adverseevents.
- NUPLAZID was effective in both treatment naïve and prior antipsychoticfailure patients.
- For those who failed NUPLAZID, improvement with a subsequentantipsychotic was uncommon.
- There was no increase in mortality detected in users of NUPLAZID.
- 6 of the 88 patients treated with NUPLAZID died (compared to 5 outof 14 in the group that never started NUPLAZID).
“This retrospective chart review provides relevant clinical experiencedata on treatment patterns in a Parkinson’s disease psychosis cohort,”said
Pimavanserin Use in a
(Poster #065)
Researchers from theParkinson’s Disease and Movement Disorders Center at
- 65% reported improvement of hallucinations with NUPLAZID.
- Six of the nine patients originally prescribed an earlier generationantipsychotic (either quetiapine or olanzapine) were able todiscontinue those drugs following NUPLAZID initiation and remained onNUPLAZID monotherapy.
- No major side effects were reported.
“Our study was based on real-life experience and shows that NUPLAZID isa beneficial and well-tolerated treatment for PD Psychosis,” said
About Parkinson’s Disease Psychosis
According to theParkinson’s Foundation, about one million people in
About NUPLAZID® (pimavanserin)
NUPLAZIDis the first FDA-approved treatment for hallucinations and delusionsassociated 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
ACADIA is a biopharmaceuticalcompany focused on the development and commercialization of innovativemedicines to address unmet medical needs in central nervous systemdisorders. 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 e-mail alerts.
Forward-Looking Statements
Statements in this press releasethat are not strictly historical in nature are forward-lookingstatements. These statements include but are not limited to statementsrelated to the benefits to be derived from NUPLAZID and to any futurestudies with NUPLAZID. These statements are only predictions based oncurrent information 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,approval and commercialization, and the fact that past results ofclinical trials may not be indicative of future trial results. For adiscussion of these and other factors, please refer to ACADIA’s annualreport on Form 10-K for the year ended December 31, 2017 as well asACADIA’s subsequent filings with the Securities and Exchange Commission.You are cautioned not to place undue reliance on these forward-lookingstatements, which speak only as of the date hereof. This caution is madeunder the safe harbor provisions of the Private Securities LitigationReform Act of 1995. All forward-looking statements are qualified intheir entirety by this cautionary statement and ACADIA undertakes noobligation to revise or update this press release to reflect events orcircumstances after the date hereof, except as required by law.
Important Safety Information and Indication forNUPLAZID (pimavanserin) tablets
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITHDEMENTIA-RELATED PSYCHOSIS
Elderly patients withdementia-related psychosis treated with antipsychotic drugs are at anincreased risk of death. NUPLAZID is not approved for the treatment ofpatients with dementia-related psychosis unrelated to the hallucinationsand delusions associated with Parkinson’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:Themost common adverse reactions(≥2%for NUPLAZID and greater than placebo) wereperipheral 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.
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:
ACADIA Pharmaceuticals Inc.
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LisaBarthelemy
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ir@acadia-pharm.com
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