SAN DIEGO--(BUSINESS WIRE)--Apr. 25, 2019--
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company
focused on the development and commercialization of innovative medicines
to address unmet medical needs in central nervous system (CNS)
disorders, today announced the initiation of the Phase 3 CLARITY-2 study
and plans to initiate the Phase 3 CLARITY-3 study in the upcoming
months. These studies will evaluate the efficacy and safety of
pimavanserin as adjunctive treatment in patients with major depressive
disorder (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). Pimavanserin is a selective serotonin inverse agonist
preferentially targeting 5-HT2A receptors, which may play a
role in depression.
“We are pleased to announce the initiation of the Phase 3 CLARITY
program. The results observed in the original Phase 2 CLARITY study
showed significant promise for patients with MDD, including a
significant antidepressant response, improvement in disability,
decreased daytime sleepiness, no meaningful weight gain, and improved
sexual function,” said Serge Stankovic, M.D., M.S.P.H., ACADIA’s
President. “We believe pimavanserin has the potential to be a very
important treatment option for the millions of MDD patients where there
remains unmet medical need. Based on feedback we received from the U.S.
FDA, if we’re successful in the Phase 3 program, we plan to use the
Phase 2 CLARITY study and positive study results from at least one of
these two Phase 3 studies to support a supplemental NDA submission.”
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 SSRI or a SNRI. CLARITY-2 will enroll
approximately 280 patients in the U.S. and CLARITY-3 will enroll
approximately 280 patients internationally. Patients in both studies
will be 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
Patients who complete the CLARITY-2 or CLARITY-3 studies will be
eligible to participate in a 52-week open-label extension study to
evaluate the long-term safety and tolerability of pimavanserin.
CLARITY was a Phase 2, 10-week, randomized,
double-blind, placebo-controlled, multi-center, 2-stage sequential
parallel comparison design 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 MGH
Clinical Trials Network & Institute and randomized 207 patients across
28 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
About Major Depressive Disorder (MDD)
According to the
National Institute of Mental Health, MDD affects approximately 16
million adults in the U.S.1, with approximately 2.5 million
adults treated with adjunctive therapy2,3. 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 therapy4.
Pimavanserin is a selective serotonin
inverse agonist preferentially targeting 5-HT2A receptors.
These receptors are thought to play an important role in depression,
psychosis, and other neuropsychiatric disorders. ACADIA is evaluating
pimavanserin in an extensive clinical development program across
multiple indications with significant unmet need including
dementia-related psychosis, schizophrenia inadequate response,
schizophrenia-negative symptoms, and major depressive disorder.
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 the adjunctive treatment of patients with
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, schizophrenia inadequate
response, schizophrenia-negative symptoms, major depressive disorder,
and Rett syndrome. This press release and further information about
ACADIA can be found at: www.acadia-pharm.com.
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 MDD 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 discovery, 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, 2018 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.
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).
Important Safety Information and Indication for
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
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 CYP3A4 inducers may reduce NUPLAZID exposure. Monitor patients
for reduced efficacy and an increase in NUPLAZID dosage may be needed.
Pediatric Use: Safety and efficacy have not been established in
Dosage and Administration: Recommended dose: 34 mg taken orally
once daily, without titration.
Indication: NUPLAZID is an atypical antipsychotic indicated for
the treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis.
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088. You can also call ACADIA Pharmaceuticals Inc. at
NUPLAZID is available as 34 mg capsules and 10 mg tablets.
Please see the full Prescribing Information including Boxed WARNING for
NUPLAZID at https://www.nuplazid.com/pdf/NUPLAZID_Prescribing_Information.pdf.
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Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.