Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a
biopharmaceutical company focused on the development and
commercialization of therapeutics for central nervous system (CNS)
disorders, today announced that the U.S. Food and Drug
Administration (FDA) has accepted for review its supplemental New
Drug Applications (sNDAs) for lumateperone, an investigational
agent for the treatment of depressive episodes associated with
bipolar I or II disorder (bipolar depression) as monotherapy and as
adjunctive therapy with lithium or valproate. The FDA has assigned
a Prescription Drug User Fee Act (PDUFA) target action date of
December 17, 2021 for the applications. If approved, CAPLYTA has
the potential to be an important medicine for a broad group of
patients suffering from these highly prevalent, chronic complex
conditions.
Two positive Phase 3 global placebo-controlled bipolar
depression studies, Study 402 and Study 404, form the basis of the
CAPLYTA sNDAs for the treatment of bipolar depression. In these
clinical trials, lumateperone 42 mg demonstrated a favorable
tolerability and safety profile consistent with findings in all of
our previous studies in schizophrenia. The most commonly reported
adverse events (defined as a rate greater than or equal to 5% and
at least twice the rate of placebo) were somnolence, dizziness and
nausea. Importantly, the rates of akathisia, restlessness and
extrapyramidal symptoms were low and similar to placebo.
“We are pleased that the FDA has accepted our sNDAs for review
and we look forward to working with the FDA during the review
process,” said Dr. Sharon Mates, Chairman and CEO
of Intra-Cellular Therapies. “We believe CAPLYTA has the
potential to be an important option for patients in the treatment
of bipolar depression.”
About Bipolar Depression
Bipolar I and Bipolar II disorder are serious, highly prevalent
psychiatric conditions affecting approximately 11 million adults in
the U.S.
These disorders are characterized by recurrent episodes of mania
or hypomania interspersed with episodes of major depression known
as Bipolar depression. Bipolar I and Bipolar II each represent
about half of the overall population of patients with bipolar
disorder.
Bipolar depression is the most common clinical presentation of
bipolar disorder. These episodes tend to last longer, recur more
often, and are associated with a worse prognosis than the
manic/hypomanic episodes. Bipolar depression remains a
significantly underserved medical need, with only a
few FDA-approved treatment options available. These treatments
are commonly associated with tolerability issues.
CAPLYTA® (lumateperone) is under investigation for the treatment
of bipolar disorder. The safety and efficacy for this use has not
been established.
CAPLYTA is indicated for the treatment of schizophrenia in
adults. CAPLYTA is available in 42 mg capsules.
Important Safety Information
Boxed Warning: Elderly patients with dementia-related
psychosis treated with antipsychotic drugs are at an increased risk
of death. CAPLYTA is not approved for the treatment of patients
with dementia-related psychosis.
Contraindications: CAPLYTA is contraindicated
in patients with known hypersensitivity to lumateperone or any
components of CAPLYTA. Reactions have included pruritus, rash (e.g.
allergic dermatitis, papular rash, and generalized rash), and
urticaria.
Warnings & Precautions: Antipsychotic drugs
have been reported to cause:
- Cerebrovascular Adverse Reactions in Elderly Patients
with Dementia-Related Psychosis, including stroke and
transient ischemic attack. See Boxed Warning above.
- Neuroleptic Malignant Syndrome (NMS), which is
a potentially fatal reaction. Signs and symptoms include: high
fever, stiff muscles, confusion, changes in breathing, heart rate,
and blood pressure, elevated creatinine phosphokinase,
myoglobinuria (and/or rhabdomyolysis), and acute renal failure.
Patients who experience signs and symptoms of NMS should
immediately contact their doctor or go to the emergency room.
- Tardive Dyskinesia, a syndrome of uncontrolled
body movements in the face, tongue, or other body parts, which may
increase with duration of treatment and total cumulative dose. TD
may not go away, even if CAPLYTA is discontinued. It can also occur
after CAPLYTA is discontinued.
- Metabolic Changes, including hyperglycemia,
diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in
some cases extreme and associated with ketoacidosis, hyperosmolar
coma or death, has been reported in patients treated with
antipsychotics. Measure weight and assess fasting plasma glucose
and lipids when initiating CAPLYTA and monitor periodically during
long-term treatment.
- Leukopenia, Neutropenia, and Agranulocytosis (including
fatal cases). Complete blood counts should be performed in
patients with pre-existing low white blood cell count (WBC) or
history of leukopenia or neutropenia. CAPLYTA should be
discontinued if clinically significant decline in WBC occurs in
absence of other causative factors.
- Decreased Blood Pressure & Dizziness.
Patients may feel lightheaded, dizzy or faint when they rise too
quickly from a sitting or lying position (orthostatic hypotension).
Heart rate and blood pressure should be monitored and patients
should be warned with known cardiovascular or cerebrovascular
disease. Orthostatic vital signs should be monitored in patients
who are vulnerable to hypotension.
- Falls. CAPLYTA may cause sleepiness or
dizziness and can slow thinking and motor skills, which may lead to
falls and, consequently, fractures and other injuries. Patients
should be assessed for risk when using CAPLYTA.
- Seizures. CAPLYTA should be used cautiously in
patients with a history of seizures or with conditions that lower
seizure threshold.
- Sleepiness and Trouble Concentrating. Patients
should use caution when operating machinery or motor vehicles until
they know how CAPLYTA affects them.
- Body Temperature Dysregulation. CAPLYTA should
be used with caution in patients who may experience conditions that
may increase core body temperature such as strenuous exercise,
extreme heat, dehydration, or concomitant anticholinergics.
- Dysphagia. CAPLYTA should be used with caution
in patients at risk for aspiration.
Drug Interactions: CAPLYTA should not be used
with CYP3A4 inducers, moderate or strong CYP3A4 inhibitors and UGT
inhibitors.
Special Populations: Newborn infants exposed to
antipsychotic drugs during the third trimester of pregnancy are at
risk for extrapyramidal and/or withdrawal symptoms following
delivery. Breastfeeding is not recommended. Use of CAPLYTA should
be avoided in patients with moderate or severe liver problems.
Adverse Reactions: The most common adverse
reactions in clinical trials with CAPLYTA vs. placebo were
somnolence/sedation (24% vs. 10%) and dry mouth (6% vs. 2%).
Please click here to see full Prescribing Information
including Boxed Warning.
About CAPLYTA (lumateperone)
CAPLYTA 42mg/day is an oral, once daily atypical antipsychotic
approved for the treatment of schizophrenia of adults. While the
mechanism of action of CAPLYTA in the treatment of schizophrenia is
unknown, the efficacy of CAPLYTA could be mediated through a
combination of antagonist activity at central serotonin 5-HT2A
receptors and postsynaptic antagonist activity at central dopamine
D2 receptors.
Lumateperone is being investigated for the treatment of bipolar
depression, depression and other neuropsychiatric and neurological
disorders. Lumateperone is not FDA approved for these
disorders.
About Intra-Cellular Therapies
Intra-Cellular Therapies is a biopharmaceutical company
founded on Nobel prize-winning research that allows us to
understand how therapies affect the inner-workings of cells in the
body. The company leverages this intracellular approach to develop
innovative treatments for people living with complex psychiatric
and neurologic diseases. For more information, please
visit www.intracellulartherapies.com.
Forward-Looking Statements
This news release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties that could cause actual
results to be materially different from historical results or from
any future results expressed or implied by such forward-looking
statements. Such forward-looking statements include statements
regarding, among other things, expectations regarding the sNDAs,
including the adequacy of the data contained in the sNDAs to serve
as the basis for approval of lumateperone for the treatment of
depressive episodes associated with bipolar I or II disorder both
as monotherapy and as adjunctive therapy in adults; potential
approval by the FDA of the sNDAs for lumateperone for the treatment
of bipolar depression; the potential timing of review and action by
the FDA with respect to the sNDAs; our belief that lumateperone has
the potential to be an important medicine for a broad group of
patients suffering from these highly prevalent, chronic complex
conditions; our belief that lumateperone has the potential to
represent an important option for patients in the treatment of
bipolar depression; our beliefs about the potential utility of our
product candidates; and development efforts and plans under the
caption “About Intra-Cellular Therapies.” All such forward-looking
statements are based on management's present expectations and are
subject to certain factors, risks and uncertainties that may cause
actual results, outcome of events, timing and performance to differ
materially from those expressed or implied by such statements.
These risks and uncertainties include, but are not limited to, the
following: whether the preclinical and clinical results of the
lumateperone studies will meet the regulatory requirements for
approval by the FDA for the proposed indications; whether
the sNDAs will be approved by the FDA and whether the FDA will
complete its review within its target timelines, including its
target action date; whether the FDA will require additional
information, whether we will be able to provide in a timely manner
any additional information that the FDA requests, and whether such
additional information will be satisfactory to the FDA; there are
no guarantees that CAPLYTA will be commercially successful; we may
encounter issues, delays or other challenges in commercializing
CAPLYTA; the COVID-19 pandemic may negatively impact our commercial
plans and sales for CAPLYTA; the COVID-19 pandemic may negatively
impact the conduct of, and the timing of enrollment, completion and
reporting with respect to, our clinical trials; whether CAPLYTA
receives adequate reimbursement from third-party payors; the degree
to which CAPLYTA receives acceptance from patients and physicians
for its approved indication; challenges associated with execution
of our sales activities, which in each case could limit the
potential of our product; results achieved in CAPLYTA in the
treatment of schizophrenia following commercial launch of the
product may be different than observed in clinical trials, and may
vary among patients; any other impacts on our business as a result
of or related to the COVID-19 pandemic; risks associated with our
current and planned clinical trials; we may encounter unexpected
safety or tolerability issues with CAPLYTA following commercial
launch for the treatment of schizophrenia or in ongoing or future
trials and other development activities; our other product
candidates may not be successful or may take longer and be more
costly than anticipated; product candidates that appeared promising
in earlier research and clinical trials may not demonstrate safety
and/or efficacy in larger-scale or later clinical trials or in
clinical trials for other indications; our proposals with respect
to the regulatory path for our product candidates may not be
acceptable to the FDA; our reliance on collaborative partners and
other third parties for development of our product candidates; and
the other risk factors detailed in our public filings with the
Securities and Exchange Commission. All statements contained in
this press release are made only as of the date of this press
release, and we do not intend to update this information unless
required by law.
Contact:
Intra-Cellular Therapies, Inc.
Juan Sanchez, M.D. Vice President, Corporate Communications and
Investor Relations646-440-9333
Burns McClellan, Inc.Lisa
Burnscradinovic@burnsmc.com212-213-0006
MEDIA INQUIRIES:
Ana FullmerCorporate Media Relations
W2Owcgafullmer@wcgworld.com202-507-0130
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