— Pimavanserin as adjunctive treatment to
SSRI/SNRI therapies significantly improved sexual dysfunction
symptoms compared to placebo in MDD patients
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that
based on secondary analyses from its Phase 2 CLARITY study,
adjunctive pimavanserin showed the potential to improve symptoms of
sexual dysfunction experienced by patients with major depressive
disorder (MDD). These additional data were presented in the poster,
“Improvement of Sexual Function Observed During Treatment of Major
Depressive Disorder With Adjunctive Pimavanserin” at the 2019 Psych
Congress, October 3-6 in San Diego, California.
The CLARITY study was a 10-week, double-blind,
placebo-controlled, two-stage sequential parallel comparison design
(SPCD) study, which evaluated the efficacy, safety, and
tolerability of pimavanserin as an adjunctive treatment for MDD in
patients who have had an inadequate response to SSRI or SNRI
therapy. In the study, pimavanserin met the overall primary
endpoint, the key secondary endpoint, and seven of the eleven
pre-specified additional secondary endpoints, including the
Massachusetts General Hospital Sexual Functioning Index (MGH-SFI)
(nominal p=0.0003)1. In addition, in Stage 1, the all-inclusive,
parallel design portion of the study (n=207), adjunctive
pimavanserin showed significant improvement relative to placebo on
mean MGH-SFI scores from baseline after five weeks of treatment
(nominal p=0.0002; effect size=0.614).
“Sexual dysfunction occurs in 40%-60% of patients with major
depressive disorder, due to either the illness itself and or the
effects of antidepressant treatment2, and is a troublesome side
effect for patients who struggle with depression,” said Marlene P.
Freeman, M.D., Associate Professor of Psychiatry, Harvard Medical
School and the Abra Prentice Foundation Chair in Women’s Mental
Health at Massachusetts General Hospital and co-author of the
study. “These results show the potential of adjunctive pimavanserin
to not only decrease depressive symptoms, but also address some of
the sexual dysfunction observed in MDD patients treated with
SSRI/SNRI antidepressant therapy.”
“The results of the Phase 2 CLARITY study suggest pimavanserin
may represent a novel approach to adjunctive treatment for patients
suffering from MDD, including these positive data on sexual
dysfunction symptoms observed in pimavanserin patients treated with
SSRI/SNRIs. In the study we also observed important additional
improvements for patients with MDD, including early and sustained
antidepressant response over placebo, decreased daytime sleepiness
with overall favorable tolerability,” said Serge Stankovic, M.D.,
M.S.P.H., ACADIA’s President. “We look forward to further confirm
these findings in our ongoing Phase 3 CLARITY program.”
About the Phase 2 CLARITY Study The study was conducted in
collaboration with the MGH Clinical Trials Network & Institute
(CTNI) and randomized 207 adult patients with a confirmed
inadequate response to existing first-line selective serotonin
reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake
inhibitor (SNRI) therapy for MDD across 27 U.S. clinical research
centers.
Consistent with the SPCD design, the study was conducted in two,
five-week sequential stages. Eligible subjects continued receiving
their SSRI or SNRI antidepressant at a stable dose for the duration
of the study. Patients were randomly assigned (1:3) to pimavanserin
34 mg/day or placebo in Stage 1. Placebo non-responders in Stage 1
(defined as HAMD-17 total score >14 and a percent-reduction from
baseline in HAMD-17 total score of <50% at week 5) were
re-randomized (1:1) to Stage 2 to receive pimavanserin 34 mg/day or
placebo. The primary endpoint of the study was the change in
HAMD-17 total score for Stage 1 and Stage 2. Treatment differences
from Stage 1 and Stage 2 were combined as weighted averages.
About Major Depressive Disorder According to the National
Institute of Mental Health, MDD affects approximately 16 million
adults in the U.S.3, with approximately 2.5 million adults treated
with adjunctive therapy.4,5 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.6
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, schizophrenia, major depressive
disorder, 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 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 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.
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
1Fava M, Dirks B, Freeman MP, et al. A phase 2, randomized,
double-blind, placebo-controlled study of adjunctive pimavanserin
in patients with major depressive disorder and an inadequate
response to therapy (CLARITY). J Clin Psychiatry.
2019;80(6):19m12928. 2Clayton AH, El Haddad S, Iluonakhamhe J-P, et
al. Sexual dysfunction associated with major depressive disorder
and antidepressant treatment. Expert Opin Drug Saf.
2014;13(10):1361 1374. PubMed CrosRef. 3National Institute of
Mental Health. (2017). Major Depression. Retrieved from
http://www.nimh.nih.gov/health/statistics/major-depression.shtml
4IMS NSP, NPA, NDTI MAT-24 month data through Aug 2017. 5PLOS One,
Characterization of Treatment Resistant Depression Episodes in a
Cohort of Patients from a US Commercial Claims Database, Oct 2013,
Vol 8, Issue 10. 6Rush AJ, et al. (2007) Am J. Psychiatry 163:11,
pp. 1905-1917 (STAR*D Study).
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Investor Contact: ACADIA Pharmaceuticals Inc. Mark Johnson, CFA
(858) 261-2771 ir@acadia-pharm.com
Media Contact: ACADIA Pharmaceuticals Inc. Maurissa Messier
(858) 768-6068 media@acadia-pharm.com
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