– New Dosing Formulation and Strength Address Needs inTreating Patients with Hallucinations and Delusions Associated withParkinson’s Disease Psychosis
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NUPLAZID® (pimavanserin) bottle (Photo: Business Wire)
The
“We are very pleased with the
“NUPLAZID is a significant advance in our treatments for thehallucinations and delusions in Parkinson's disease,” said Dr.
The NUPLAZID 34 mg capsules and 10 mg tablets will be available bymid-August.
About Parkinson’s Disease Psychosis
According to theParkinson’s Foundation, about one million people in the
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. ACADIAdiscovered and developed 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 has developed and is commercializing the first andonly medicine approved for the treatment of hallucinations and delusionsassociated with Parkinson’s disease psychosis. In addition, ACADIA hasongoing clinical development efforts in additional areas withsignificant unmet need including dementia-related psychosis,schizophrenia inadequate response, schizophrenia-negative symptoms andmajor depressive disorder. This press release and further informationabout ACADIA can be found at: www.acadia-pharm.com.
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 timing of the availability of 34 mg capsules and 10 mgtablets of NUPLAZID, and the benefits to be derived from NUPLAZID. 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 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 December 31, 2017 as well as ACADIA’s subsequent filingswith the Securities and Exchange Commission. You are cautioned not toplace undue reliance on these forward-looking statements, which speakonly as of the date hereof. This caution is made under the safe harborprovisions of the Private Securities Litigation Reform Act of 1995. Allforward-looking statements are qualified in their entirety by thiscautionary statement and ACADIA undertakes no obligation to revise orupdate this press release to reflect events or circumstances after thedate hereof, except as required by law.
Important Safety Information and Indication forNUPLAZID (pimavanserin)
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: 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.
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:
Taft Communications
Bob Laverty
(609)558-5570
bob@taftcommunications.com