- Concurrently, the Company Has Issued a Press Release Announcing thePresentation of Clinical Experience Data for NUPLAZID at the AmericanAcademy of Neurology (AAN) Annual Meeting
SAN DIEGO—(BUSINESS WIRE)—Apr. 27, 2018—ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today issued the followingstatement:
NUPLAZID® (pimavanserin) is the only medicine approved in theUnited States to treat hallucinations and delusions associated withParkinson’s disease psychosis. NUPLAZID was approved by the FDA based ona pivotal Phase 3 study that demonstrated clinically robust and highlystatistically significant efficacy, combined with other supportivestudies. We are confident in NUPLAZID’s efficacy and positivebenefit/risk profile and stand firmly behind it.
ACADIA’s top priority has been, and continues to be, patient safety.NUPLAZID was approved and launched in 2016. As the manufacturer of anewly launched drug, we are routinely in contact with the FDA regardingrequests for additional information on NUPLAZID, including postmarketingsafety surveillance information as part of the FDA’s ongoing safetymonitoring.
In a statement released to the media on April 10, 2018, the FDA stated,“The FDA continues to monitor adverse events reported with NUPLAZID thatare submitted to the FDA Adverse Event Reporting System (FAERS). We havenoted that the cases typically involve geriatric patients withadvanced-stage Parkinson’s disease, as well as numerous medicalconditions, who are frequently taking concomitant medications with risksfor serious adverse events, including death. Based on these data, theFDA has, at this time, not identified a specific safety issue that isnot already adequately described in the product labeling.”
On April 25, 2018, the FDA stated that its evaluation does not mean theAgency has determined the medicine has a new risk and does not suggesthealthcare providers should not prescribe it nor that patients shouldstop taking the medication. The Agency also has confirmed this statementdoes not represent a change from the safety review and monitoringactivities the FDA referred to in its statement of April 10. As always,we will continue to work with the FDA and medical community to answerany questions related to NUPLAZID.
ACADIA collects and analyzes postmarketing events for NUPLAZID as partof our ongoing commitment to monitor the medication’s safety profile.These events are submitted to the FDA and incorporated into the FDA’sFAERS public reporting system. Because NUPLAZID is distributed through aspecialty distribution channel, we have frequent (in most cases monthly)contact with patients and caregivers through our distribution partners.This increased interaction naturally results in dramatically higheradverse event collection and reporting compared to products without sucha distribution method. Approximately 93 percent of the reported adverseevents associated with NUPLAZID are considered “solicited” due to thisdirect interaction with patients and caregivers, while onlyapproximately 7 percent of these events are considered “spontaneous”reports, which are voluntary reports originating from consumers orhealthcare professionals. In contrast, most other antipsychotics aredistributed through retail channels, which rely almost entirely on“spontaneous” reporting. Consequently, only a small fraction of actualadverse events are collected for these drugs.
NUPLAZID Recent Studies Update
Since NUPLAZID’s approval, additional studies have further demonstratedits efficacy and benefit/risk profile. Simultaneous with this release,ACADIA announced the results of two independent studies presented thisweek at the American Academy of Neurology Annual Meeting. In the firststudy, a retrospective 102-patient chart review conducted by researchersat Vanderbilt University Medical Center, more than 70 percent of allpatients treated with NUPLAZID reported clinical improvement, while 88percent of patients treated longer than four weeks improved.Importantly, NUPLAZID was tolerated without significant side effects inthe majority of patients. In this study, there was no increase inmortality reported for patients taking NUPLAZID. The second study,conducted by researchers from the Parkinson’s Disease and MovementDisorders Center at Henry Ford Hospital, involved a survey of real-lifeexperience among 16 patients diagnosed with moderate to severeParkinson’s disease psychosis, which showed that NUPLAZID was awell-tolerated and effective treatment in these patients.
As part of this statement, ACADIA is providing updated safetyinformation from two recent clinical studies. Following the approval ofNUPLAZID for the treatment of hallucinations and delusions associatedwith Parkinson’s disease psychosis, ACADIA has conducted twoplacebo-controlled clinical studies in an aggregate of more than 300patients with Alzheimer’s disease (AD). In these controlled studies infrail elderly patients with dementia, there was no difference in thenumber of deaths reported between NUPLAZID (four) and placebo (four).
In addition, ACADIA has completed or is in the process of completing allof the postmarketing commitments included with the NUPLAZID approvalletter, in full compliance with the timelines defined by the FDA.
Of the approximately one million individuals in the United States livingwith Parkinson’s disease, over 50 percent will experience hallucinationsand delusions associated with Parkinson’s disease psychosis over thecourse of their disease. NUPLAZID fills a significant, previously unmetneed in the treatment of Parkinson’s disease psychosis. Patients andhealthcare professionals recognize the value of NUPLAZID, and we receivepositive feedback about the benefits it provides to patients and theirfamilies. We look forward to working closely and expeditiously with theFDA and the Parkinson’s disease community to ensure the best and safestcare of patients with Parkinson’s disease psychosis. We thank healthcareproviders for their ongoing support in raising awareness around thisdebilitating condition and take pride in the meaningful impact NUPLAZIDhas made in the lives of patients with Parkinson’s disease psychosis andthe people who care for them.
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 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 benefits to be derived from NUPLAZID(pimavanserin),the outcome of any ongoing or future evaluation by the FDA of NUPLAZID,or the timing or results of any future studies with 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) 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.
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 (e.g., 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.
Investor Contact:
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy,(858) 558-2871
ir@acadia-pharm.com
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