- Supplemental New Drug Application (sNDA) planned for
2023
WASHINGTON, Dec. 19,
2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc.
(Vanda) (Nasdaq: VNDA) today reported positive results in a Phase
III clinical study of Fanapt® (iloperidone tablets), a
novel atypical antipsychotic, in the treatment of acute manic
and mixed episodes associated with bipolar I disorder in adults.
Fanapt® is currently approved by the FDA for the
treatment of schizophrenia in adults.
In clinical study VP-VYV-683-3201 approximately 400 volunteers
with a history of bipolar I disorder suffering from a current
episode of mania were randomized to receive either
Fanapt® or placebo in a 1:1 ratio at clinical sites in
the United States, Bulgaria and Poland. The primary endpoint measured in Week
4 of treatment was assessed by the Young Mania Rating Scale (YMRS),
a rating scale of clinical severity in the core symptoms of mania.
At the end of the study (Week 4), Fanapt® treated
patients showed a larger improvement than placebo treated patients,
and this difference was highly statistically significant
(p=0.000008).
YMRS was assessed at the end of Weeks 1, 2, 3 and 4.
Statistically significant benefit in the Fanapt® group
over placebo was observed as early as the Week 2 assessment.
Consistent with the total YMRS score, the individual YMRS subscale
items also showed improvement in the Fanapt® group
versus the placebo group over the course of the 4-week study. Other
outcomes, such as Clinician Global Impression of Severity (CGI-S)
and Clinician Global Impression of Change (CGI-C), also achieved
statistical significance (p=0.0005 and p=0.0002, respectively).
"The robust clinical trial results we report today demonstrate
the potential to extend the utility of Fanapt into treating adult
patients with bipolar I disorder, in addition to the already
marketed indication of schizophrenia," said Mihael H. Polymeropoulos, M.D., Vanda's
President, CEO and Chairman of the Board. "We look forward to
submitting our supplemental New Drug Application to the FDA and
expanding the Fanapt franchise."
Bipolar disorder is highly prevalent in the United States, estimated to affect
2.8%1, of the U.S. adult population, a number
approximately up to ten times higher than the estimated prevalence
of schizophrenia2,3.
Vanda plans to submit this pivotal study data of
Fanapt® for the treatment of acute manic and mixed
episodes associated with bipolar I disorder in adults in a
supplemental New Drug Application (sNDA) in 2023.
References
- Harvard Medical School, 2007.
National Comorbidity Survey (NSC). (2017, August 21). Retrieved from
https://www.hcp.med.harvard.edu/ncs/index.php.
- Kessler, R.C., Birnbaum, H., Demler, O., Falloon, I.R., Gagnon,
E., Guyer, M., Howes, M.J., Kendler, K.S., Shi, L., Walters, E.,
Wu, E.Q. (2005). The prevalence and correlates of nonaffective
psychosis in the National Comorbidity Survey Replication (NCS-R).
Biological Psychiatry, 58(8), 668-76. doi:
10.1016/j.biopsych.2005.04.034
- Wu, E.Q., Shi, L., Birnbaum, H., Hudson, T., Kessler, R.
(2006). Annual prevalence of diagnosed schizophrenia in the
USA: a claims data analysis
approach. Psychological Medicine, 36(11), 1535-40. doi:
10.1017/S0033291706008191
About Vanda Pharmaceuticals
Inc.
Vanda is a leading global biopharmaceutical company focused on
the development and commercialization of innovative therapies to
address high unmet medical needs and improve the lives of patients.
For more on Vanda Pharmaceuticals Inc., please visit
www.vandapharma.com and follow us on Twitter @vandapharma.
About
Fanapt®
For full U.S. Prescribing Information for Fanapt®,
including indication, Boxed Warnings and Important Safety
Information, visit our Web site at www.fanapt.com.
Important Safety
Information
Fanapt® needs to be taken as directed starting at a
low dose and slowly increasing the strength. This may delay the
control of symptoms in the first 1 to 2 weeks of treatment.
Boxed 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.
Fanapt® is not approved for use in patients with
dementia-related psychosis.
Contraindications
- Known hypersensitivity to Fanapt® or to any
components in the formulation. Anaphylaxis, angioedema, and other
hypersensitivity reactions have been reported.
Warnings And Precautions
- Fanapt® is not approved for treatment of
patients with dementia-related psychosis. There was a higher
incidence of cerebrovascular adverse events, including death,
compared to placebo-treated patients.
- QT prolongation: Fanapt® prolongs QT interval
and may be associated with arrhythmia and sudden death—consider
using other antipsychotics first. Avoid use of
Fanapt® in combination with other drugs that are
known to prolong QTc; use caution and consider dose modification
when prescribing Fanapt® with other drugs that
inhibit Fanapt® metabolism. Monitor serum potassium
and magnesium in patients at risk for electrolyte
disturbances.
- Neuroleptic malignant syndrome, a potentially fatal symptom,
has been reported in association with antipsychotic drugs including
Fanapt®. Manage with immediate discontinuation of drug,
treatment if needed, and close monitoring.
- Tardive dyskinesia: The risk of tardive dyskinesia may increase
as the duration of treatment and total cumulative dose increases.
Discontinue Fanapt® if clinically appropriate.
- Metabolic changes: Atypical antipsychotic drugs have been
associated with metabolic changes that may increase
cardiovascular/cerebrovascular risk. These metabolic changes
include hyperglycemia, dyslipidemia, and weight gain. Monitor
patients for symptoms of hyperglycemia including polydipsia,
polyuria, polyphagia, and weakness. Monitor glucose regularly in
patients at risk for diabetes. Undesirable alterations in lipids
have been observed in patients treated with atypical
antipsychotics. Weight gain has been reported; monitor weight.
- Seizures: Use Fanapt® cautiously in patients
with a history of seizures or with conditions that lower seizure
threshold.
- Orthostatic hypotension: Dizziness, tachycardia, and syncope
can occur with standing. More rapid titration would be expected to
increase the rate of orthostatic hypotension and syncope.
- Fanapt® may cause somnolence, postural hypotension,
motor and sensory instability, which may lead to falls causing
fractures or other injuries. For patients with diseases,
conditions, or medications that could exacerbate these effects,
complete fall risk assessments initially and recurrently during
therapy.
- Leukopenia, neutropenia, and agranulocytosis have been reported
with antipsychotics. Patients with a pre-existing low white blood
cell count (WBC) or a history of leukopenia/neutropenia should have
their complete blood count (CBC) monitored frequently during the
first few months of therapy and should discontinue
Fanapt® at the first sign of a decline in WBC in
the absence of other causative factors.
- Hyperprolactinemia: As with other drugs that antagonize
dopamine D2 receptors, Fanapt® elevates prolactin
levels. Galactorrhea, amenorrhea, gynecomastia, and impotence have
been reported with prolactin-elevating compounds.
- Body temperature regulation: Appropriate care is advised when
prescribing Fanapt® for patients who will be
experiencing conditions which may contribute to an elevation in
core body temperature.
- Dysphagia: Esophageal dysmotility and aspiration have been
associated with antipsychotic drug use.
Fanapt® should be used cautiously in patients at
risk for aspiration pneumonia, including the elderly and those with
advanced Alzheimer's dementia.
- Suicide: Closely supervise high-risk patients.
- Priapism: Cases have been reported in association with
Fanapt® treatment.
- Potential for cognitive and motor impairment: Use caution when
operating machinery.
Adverse Reactions
- Commonly observed adverse reactions (incidence ≥5% and 2-fold
greater than placebo) were: dizziness, dry mouth, fatigue, nasal
congestion, orthostatic hypotension, somnolence, tachycardia, and
weight increased.
Drug Interactions
- The dose of Fanapt® should be reduced by
one-half in patients co-administered a strong CYP2D6 or CYP3A4
inhibitor.
Use In Specific
Populations
- Fanapt® may cause extrapyramidal symptoms
and/or withdrawal symptoms in neonates with third trimester
exposure. Nursing mothers are advised not to breastfeed while
taking Fanapt®.
- The safety and effectiveness of Fanapt® has not
been established in children and adolescents.
- Fanapt® is not recommended for patients with
severe hepatic impairment.
- The dose of Fanapt® should be reduced by
one-half in patients who are poor metabolizers of CYP2D6.
CAUTIONARY NOTE REGARDING
FORWARD-LOOKING STATEMENTS
Various statements in this press release, including, but not
limited to statements regarding Vanda's clinical development plan
and strategies for Fanapt® for the treatment of acute
manic and mixed episodes associated with bipolar I disorder in
adults, the efficacy of Fanapt®, the potential
therapeutic opportunity for Fanapt® and the prevalence
of bipolar disorder are "forward-looking statements" under the
securities laws. Forward-looking statements are based upon current
expectations that involve risks, changes in circumstances,
assumptions and uncertainties. Important factors that could cause
actual results to differ materially from those reflected in Vanda's
forward-looking statements include, among others, the ability of
Fanapt® to safely and effectively treat acute manic and
mixed episodes associated with bipolar I disorder in adults,
Vanda's ability to submit the sNDA for Fanapt® in 2023,
Vanda's ability to obtain regulatory approval for
Fanapt® in the treatment of acute manic and mixed
episodes associated with bipolar I disorder in adults and the
actual number of adults in the U.S. affected by bipolar disorder.
There can be no assurance that the actual results or developments
anticipated by Vanda will be realized or, even if substantially
realized, that they will have the expected consequences to, or
effects on, Vanda. Therefore, no assurance can be given that the
outcomes stated in such forward-looking statements and estimates
will be achieved. Forward-looking statements in this press release
should be evaluated together with the various risks and
uncertainties that affect Vanda's business and market, particularly
those identified in the "Cautionary Note Regarding Forward-Looking
Statements", "Risk Factors" and "Management's Discussion and
Analysis of Financial Condition and Results of Operations" sections
of Vanda's Annual Report on Form 10-K for the fiscal year ended
December 31, 2021, as updated by
Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports
on Form 8-K and other filings with the U.S. Securities and Exchange
Commission, which are available at www.sec.gov.
All written and verbal forward-looking statements attributable
to Vanda or any person acting on its behalf are expressly qualified
in their entirety by the cautionary statements contained or
referred to herein. Vanda cautions investors not to rely too
heavily on the forward-looking statements Vanda makes or that are
made on its behalf. The information in this press release is
provided only as of the date of this press release, and Vanda
undertakes no obligation, and specifically declines any obligation,
to update or revise publicly any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by law.
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and
Treasurer
Vanda Pharmaceuticals
Inc.
202-734-3400
pr@vandapharma.com
Elizabeth Van
Every
Head of Corporate
Affairs
Vanda Pharmaceuticals
Inc.
202-734-3400
pr@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.