ACADIA Pharmaceuticals Issues Statement Reaffirming Benefit/Risk Profile of NUPLAZID
- Concurrently, the Company Has Issued a Press Release Announcing the
Presentation of Clinical Experience Data for NUPLAZID at the
NUPLAZID® (pimavanserin) is the only medicine approved in
ACADIA’s top priority has been, and continues to be, patient safety.
NUPLAZID was approved and launched in 2016. As the manufacturer of a
newly launched drug, we are routinely in contact with the
In a statement released to the media on
On
ACADIA collects and analyzes postmarketing events for NUPLAZID as part
of our ongoing commitment to monitor the medication’s safety profile.
These events are submitted to the
NUPLAZID Recent Studies Update
Since NUPLAZID’s approval, additional studies have further demonstrated
its efficacy and benefit/risk profile. Simultaneous with this release,
ACADIA announced the results of two independent studies presented this
week at the
As part of this statement, ACADIA is providing updated safety information from two recent clinical studies. Following the approval of NUPLAZID for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, ACADIA has conducted two placebo-controlled clinical studies in an aggregate of more than 300 patients with Alzheimer’s disease (AD). In these controlled studies in frail elderly patients with dementia, there was no difference in the number of deaths reported between NUPLAZID (four) and placebo (four).
In addition, ACADIA has completed or is in the process of completing all
of the postmarketing commitments included with the NUPLAZID approval
letter, in full compliance with the timelines defined by the
Of the approximately one million individuals in
About
ACADIA is a biopharmaceutical
company focused on the development and commercialization of innovative
medicines to address unmet medical needs in central nervous system
disorders. ACADIA maintains a website at www.acadia-pharm.com
to which we regularly post copies of our press releases as well as
additional information and through which interested parties can
subscribe to receive e-mail alerts.
Forward-Looking Statements
Statements in this press release
that are not strictly historical in nature are forward-looking
statements. These statements include but are not limited to statements
related to benefits to be derived from NUPLAZID(pimavanserin),
the outcome of any ongoing or future evaluation by the
Important Safety Information and Indication for
NUPLAZID (pimavanserin) tablets
WARNING: INCREASED
MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly
patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. NUPLAZID is not approved for
the treatment of patients with dementia-related psychosis unrelated to
the hallucinations and delusions associated with Parkinson’s disease
psychosis.
NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, circumoral edema, throat tightness, and dyspnea) have been reported.
QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics. NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation 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 (e.g., ketoconazole) increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half. Strong CYP3A4 inducers may reduce NUPLAZID exposure, monitor for reduced efficacy. Increase in NUPLAZID dosage may be needed.
Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated and should therefore be used in pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
Pediatric Use: Safety and efficacy have not been established in pediatric patients.
Dosage and Administration: Recommended dose: 34 mg per day, taken orally as 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180427005265/en/
Source:
Investor Contact:
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy,
(858) 558-2871
ir@acadia-pharm.com
or
Media
Contact:
Taft Communications
Bob Laverty, (609) 558-5570
bob@taftcommunications.com