- Top-line results expected in 3Q20
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) announced today that
following positive feedback from the U.S. Food and Drug
Administration the company plans to combine its CLARITY-2 and
CLARITY-3 Phase 3 studies evaluating pimavanserin for the
adjunctive treatment of major depressive disorder (MDD) into one
study with a pre-specified statistical analysis plan. As a result,
no new patients will be enrolled in the two identically designed
Phase 3 studies, each of which will be concluded with slightly more
than 50% enrollment. Top-line results from the combined study are
expected in the third quarter of 2020.
If positive, the results from the combined study, along with the
positive results from the previously announced pivotal CLARITY
study, would form the basis for a supplemental new drug application
for pimavanserin in the adjunctive treatment of MDD.
About CLARITY-2 and CLARITY-3
CLARITY-2 and CLARITY-3 are both 6-week, parallel-designed,
randomized, double-blind, placebo-controlled, multi-center studies
designed to evaluate the efficacy and safety of pimavanserin as
adjunctive treatment in patients with MDD who have an inadequate
response to standard antidepressant therapy with either a selective
serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine
reuptake inhibitor (SNRI). Patients in both studies were randomized
to receive six weeks of oral treatment with either 34 mg of
pimavanserin or placebo, once daily, in addition to their ongoing
antidepressant. The primary endpoint in both studies is the change
from baseline on the 17-item Hamilton Depression Rating Scale
(HAMD-17) total score.
Patients who completed the Phase 3 studies were eligible to
participate in the ongoing 52-week open-label extension study to
evaluate the long-term safety and tolerability of pimavanserin in
MDD. The open-label extension study is continuing as planned.
About CLARITY
CLARITY was a Phase 2, 10-week, randomized, double-blind,
placebo-controlled, multi-center, 2-stage sequential parallel
comparison design (SPCD) study that evaluated the safety,
tolerability, and efficacy of pimavanserin (34 mg once daily) as an
adjunctive treatment in patients with MDD who had an inadequate
response to a stable dose of standard antidepressant therapy with
either a SSRI or a SNRI. The study was conducted in collaboration
with the Massachusetts General Hospital Clinical Trials Network
& Institute and randomized 207 patients across 27 clinical
research centers in the U.S.
In the trial, pimavanserin met the overall primary endpoint of
the weighted average results of Stage 1 and Stage 2 by
significantly reducing the HAMD-17 total score compared to placebo
(p=0.039). On the key secondary endpoint, pimavanserin demonstrated
statistically significant reductions compared to placebo in the
Sheehan Disability Scale score (p=0.004). Positive results were
also observed for seven other secondary endpoints including the
Karolinska Sleepiness Scale (p=0.0205) and the Massachusetts
General Hospital Sexual Functioning Index (p=0.0003).
In the parallel design portion (Stage 1) of this SPCD study,
adding pimavanserin to first-line SSRI or SNRI therapy also
significantly reduced HAMD-17 scores compared to placebo
(p=0.0003). On the key secondary endpoint, pimavanserin also
demonstrated statistically significant reductions compared to
placebo in the Sheehan Disability Scale score (p=0.004).
About Major Depressive Disorder
According to the National Institute of Mental Health, MDD
affects approximately 17 million adults in the U.S.1, with
approximately 2.5 million adults treated with adjunctive
therapy.2,3 MDD is a condition characterized by depressive symptoms
such as a depressed mood or a loss of interest or pleasure in daily
activities for more than two weeks, as well as impaired social,
occupational, or other important functioning. The majority of
people who suffer from MDD do not respond adequately to initial
antidepressant therapy.4
About Pimavanserin
Pimavanserin is a selective serotonin inverse agonist and
antagonist preferentially targeting 5-HT2A receptors. These
receptors are thought to play an important role in psychosis,
schizophrenia, depression and other neuropsychiatric disorders. In
vitro, pimavanserin demonstrated no appreciable binding affinity
for dopamine (including D2), histamine, muscarinic, or adrenergic
receptors. ACADIA is evaluating pimavanserin in an extensive
clinical development program across multiple indications with
significant unmet need including dementia-related psychosis,
adjunctive major depressive disorder, and the negative symptoms of
schizophrenia. Pimavanserin was approved for the treatment of
hallucinations and delusions associated with Parkinson’s disease
psychosis by the U.S. Food and Drug Administration in April 2016
under the trade name NUPLAZID®. NUPLAZID is not approved for
dementia-related psychosis, schizophrenia or major depressive
disorder.
About ACADIA Pharmaceuticals
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 has
developed and commercialized the first and only medicine approved
for the treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis. ACADIA also has ongoing clinical
development efforts in additional areas with significant unmet
need, including dementia-related psychosis, major depressive
disorder, the negative symptoms of schizophrenia, and Rett
syndrome. This press release and further information about ACADIA
can be found at: www.acadia-pharm.com.
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
the potential benefits of pimavanserin as adjunctive treatment for
major depressive disorder or other central nervous system disorders
as well as the potential results of clinical trials of pimavanserin
in other indications. These statements are only predictions based
on current information and expectations and involve a number of
risks and uncertainties. Actual events or results may differ
materially from those projected in any of such statements due to
various factors, including the risks and uncertainties inherent in
drug development, approval and commercialization, and the fact that
past results of clinical trials may not be indicative of future
trial results. For a discussion of these and other factors, please
refer to ACADIA’s annual report on Form 10-K for the year ended
December 31, 2019 as well as ACADIA’s subsequent filings with the
Securities and Exchange Commission. You are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date hereof. This caution is made under the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. All forward-looking statements are qualified in their
entirety by this cautionary statement and ACADIA undertakes no
obligation to revise or update this press release to reflect events
or circumstances after the date hereof, except as required by
law.
Important Safety Information and
Indication for NUPLAZID (pimavanserin)
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.
- 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: The most common adverse reactions
(≥2% for NUPLAZID and 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 mg taken orally as one tablet once daily.
- Coadministration with strong or moderate CYP3A4 inducers
reduces NUPLAZID exposure. Avoid concomitant use of strong or
moderate CYP3A4 inducers with NUPLAZID.
Indication: NUPLAZID is indicated for the treatment of
hallucinations and delusions associated with Parkinson’s disease
psychosis.
Dosage and Administration: Recommended dose: 34 mg
capsule taken orally once daily, without titration.
NUPLAZID is available as 34 mg capsules and 10 mg tablets.
Please see the full Prescribing Information including Boxed
WARNING for NUPLAZID.
References:
1National Institute of Mental Health. (2017). Major Depression.
Retrieved from
http://www.nimh.nih.gov/health/statistics/major-depression.shtml
2IMS NSP, NPA, NDTI MAT-24 month data through Aug 2017.
3PLOS One, Characterization of Treatment Resistant Depression
Episodes in a Cohort of Patients from a US Commercial Claims
Database, Oct 2013, Vol 8, Issue 10.
4Rush AJ, et al. (2007) Am J. Psychiatry 163:11, pp. 1905-1917
(STAR*D Study).
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version on businesswire.com: https://www.businesswire.com/news/home/20200526005118/en/
Media Contact: ACADIA Pharmaceuticals Inc. Stephanie Fagan (858)
212-0534 media@acadia-pharm.com
Investor Contact: ACADIA Pharmaceuticals Inc. Mark Johnson, CFA
(858) 261-2771 ir@acadia-pharm.com
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