- FDA analysis finds no new or unexpected safety risks associatedwith NUPLAZID
- Patients taking NUPLAZID for Parkinson’sdisease psychosis should continue to use it as prescribed by theirhealth care provider
- FDA also reminds health care providersthat no other antipsychotic medication is approved for the treatment ofParkinson’s disease psychosis
SAN DIEGO—(BUSINESS WIRE)—Sep. 20, 2018—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) today announced that the FDAhas completed a postmarketing review and issued a clear statementreaffirming the positive benefit-risk profile of NUPLAZID (pimavanserin)for patients with Parkinson’s disease psychosis. NUPLAZID is the onlymedicine approved in the United States to treat hallucinations anddelusions associated with Parkinson’s disease psychosis (PDP). NUPLAZIDwas approved by the FDA based on a pivotal Phase 3 study thatdemonstrated clinically robust and highly statistically significantefficacy, combined with other supportive studies.
Following the FDA’s review, the FDA concluded, “The U.S. FDA hascompleted a review of all postmarketing reports of deaths and seriousadverse events (SAEs) reported with the use of NUPLAZID. Based on ananalysis of all available data, FDA did not identify any new orunexpected safety findings with NUPLAZID, or findings that areinconsistent with the established safety profile currently described inthe drug label. After a thorough review, FDA’s conclusion remainsunchanged that the drug’s benefits outweigh its risks for patients withhallucinations and delusions of Parkinson’s disease psychosis.” Inaddition, the FDA stated that, “patients taking NUPLAZID for Parkinson’sdisease psychosis should continue to use it as prescribed by theirhealth care providers. Based on this observation, FDA reminds healthcare providers to be aware of the risks described in the prescribinginformation. FDA also reminds health care providers that none of theother antipsychotic medications are approved for the treatment ofParkinson’s disease psychosis.”
“Nothing is more important to ACADIA than the wellbeing of the patientswho use NUPLAZID. We are very pleased with the FDA’s clear statementreaffirming NUPLAZID’s positive benefit-risk profile,” said Steve Davis,ACADIA’s President and Chief Executive Officer. “We are also pleasedwith the FDA’s conclusion that patients taking NUPLAZID for Parkinson’sdisease psychosis should continue to use it as prescribed by theirhealth care provider and its reminder that no other antipsychoticmedication is approved for the treatment of PDP.”
FDA Full Statement
FDA analysis finds no new or unexpected safety risks associated withNUPLAZID (pimavanserin), a medication to treat the hallucinations anddelusions of Parkinson’s disease psychosis (Link)
Health care providers reminded to follow prescribing information
[09-20-2018] The U.S. Food and Drug Administration (FDA) has completed areview of all postmarketing reports of deaths and serious adverse events(SAEs) reported with the use of NUPLAZID (pimavanserin). Based on ananalysis of all available data, FDA did not identify any new orunexpected safety findings with NUPLAZID, or findings that areinconsistent with the established safety profile currently described inthe druglabel. After a thorough review, FDA’s conclusion remains unchangedthat the drug’s benefits outweigh its risks for patients withhallucinations and delusions of Parkinson’s disease psychosis.
NUPLAZID and other antipsychotics have a Boxed Warning regarding theincreased risk of death in elderly patients with dementia-relatedpsychosis associated with the use of these drugs. In view of the numbersof reports of death and other serious adverse events, FDA conducted acomprehensive analysis of all available information. This analysisincluded information submitted to the FDA Adverse Event Reporting System(FAERS), drug utilization data, safety data from the NUPLAZID new drugapplication, the sponsor’s Periodic Adverse Drug Experience Reports, thesponsor’s analysis of fatal adverse event reports with NUPLAZID andpublished medical literature.
In assessing the reports of deaths, FDA considered that patients withParkinson’s disease psychosis, for whom NUPLAZID is indicated, have ahigher mortality (death) rate due to their older age, advancedParkinson’s disease, and other medical conditions. Moreover, NUPLAZID isprimarily distributed through a patient support program and a specialtypharmacy network, which increases the likelihood that deaths will bereported to the manufacturer. In FAERS reports that included a cause ofdeath (many reports did not provide sufficient information to assessdrug cause and effect), there was no evident pattern to suggest a drugeffect. Overall, the postmarketing data were consistent with the safetydata obtained from the premarketing controlled clinical trials ofNUPLAZID for Parkinson’s disease psychosis.
Although FDA did not identify any new or unexpected safety risks, somepotentially concerning prescribing patterns were observed, such as theconcomitant use of other antipsychotic drugs or drugs that can cause QTprolongation, a potential cause of heart rhythm disorder. The risk of QTprolongation and serious arrhythmia (abnormal heart rhythm) associatedwith NUPLAZID is noted in the Warnings and Precautions section of thedrug label, which warns of the increased risks associated with usingNUPLAZID together with other drugs known to cause QT intervalprolongation. Based on this observation, FDA reminds health careproviders to be aware of the risks described in the prescribinginformation. FDA also reminds health care providers that none of theother antipsychotic medications are approved for the treatment ofParkinson’s disease psychosis.
Patients taking NUPLAZID for Parkinson’s disease psychosis shouldcontinue to use it as prescribed by their health care provider. FDAcontinues to monitor reports of adverse events associated with NUPLAZID.The agency will communicate any updates to the public as necessary. Tohelp FDA assess potential medication safety issues, we urge health careproviders and patients to report suspected side effects involvingNUPLAZID and other drugs to the FDAMedWatch program.
End of FDA Full Statement
About Parkinson’s Disease Psychosis
According to theParkinson’s Foundation, about one million people in the United Statesand from four to six million people worldwide suffer from Parkinson’sdisease. More than 50 percent of people with Parkinson’s will experiencesymptoms of psychosis over the course of their disease. PD Psychosis ischaracterized by hallucinations and delusions, is associated withsignificant caregiver burden, and is a major reason for nursing homeplacement among Parkinson’s patients.
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 Pharmaceuticals
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,major depressive disorder and Rett syndrome. This press release andfurther information about 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 benefits to be derived from NUPLAZID. These statementsare only predictions based on current information and expectations andinvolve a number of risks and uncertainties. Actual events or resultsmay differ materially from those projected in any of such statements dueto various factors, including the risks and uncertainties inherent indrug discovery, development, approval and commercialization, and thefact that past results of clinical trials may not be indicative offuture trial results. For a discussion of these and other factors,please refer to ACADIA’s annual report on Form 10-K for the year endedDecember 31, 2017 as well as ACADIA’s subsequent filings with theSecurities and Exchange Commission. You are cautioned not to place unduereliance on these forward-looking statements, which speak only as of thedate hereof. This caution is made under the safe harbor provisions ofthe 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.
NUPLAZID is available as 34 mg capsules, 17 mg tablets and 10 mg tablets.
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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