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-3CLARITY-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 score.
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.
About CLARITYCLARITY 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 Index (p=0.0003).
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.
About PimavanserinPimavanserin 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 PharmaceuticalsACADIA 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.
Forward-Looking StatementsStatements 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.
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).
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 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 pediatric patients.
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
1-844-4ACADIA (1-844-422-2342).
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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version on businesswire.com: https://www.businesswire.com/news/home/20190425005313/en/
Investor Contact:ACADIA Pharmaceuticals Inc.Mark Johnson,
CFA(858) 261-2771ir@acadia-pharm.com
Media Contact:ACADIA Pharmaceuticals Inc.Maurissa Messier(858)
768-6068media@acadia-pharm.com
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