DUBLIN, Aug. 21, 2020 /PRNewswire/ -- Alkermes
plc (Nasdaq: ALKS) today announced that a joint meeting of the
U.S. Food and Drug Administration's (FDA) Psychopharmacologic Drugs
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee to review the New Drug Application (NDA) for ALKS 3831
(olanzapine/samidorphan) has been tentatively scheduled for
Oct. 9, 2020. ALKS 3831 is an
investigational, novel, once-daily, oral atypical antipsychotic
drug candidate for the treatment of adults with schizophrenia and
for the treatment of adults with bipolar I disorder. The
Prescription Drug User Fee Act (PDUFA) action date for the ALKS
3831 NDA is Nov. 15, 2020.
It is expected that the advisory committee panel will review the
efficacy, safety, and benefit-risk profile of ALKS 3831 for the
proposed indications of schizophrenia and bipolar I disorder. As
announced previously, the company expects the advisory panel to
focus on the clinical meaningfulness of ALKS 3831's attenuation of
olanzapine-associated weight gain, including the magnitude of
weight effect and the impact of ALKS 3831 on laboratory-based
metabolic parameters. Since that time, the company has learned that
the panel will also discuss certain potential clinical risks
related to the interaction of ALKS 3831, which includes
samidorphan, an opioid receptor antagonist, and opioids in the
intended patient populations.
"We look forward to engaging with members of the joint advisory
committee panel in a robust discussion of the clinical evidence for
ALKS 3831," said Craig Hopkinson,
M.D., Chief Medical Officer and Executive Vice President of
Research & Development at Alkermes. "For adults living with
schizophrenia or bipolar I disorder, populations already prone to
shortened life expectancy and cardiovascular comorbidities, the
significant weight gain often associated with olanzapine can
represent a major clinical liability. Patients and healthcare
providers may benefit from additional treatment options that help
manage disease symptoms while mitigating weight gain. We are
committed to bringing this potential new medicine to adults living
with schizophrenia or bipolar I disorder."
The NDA submission and clinical development program for ALKS
3831 are supported by data from 27 clinical studies, including
18 studies evaluating ALKS 3831 and nine studies
evaluating samidorphan alone. Throughout the clinical
development program, ALKS 3831 showed evidence of antipsychotic
efficacy, safety and tolerability, including attenuation of
olanzapine-associated weight gain.
About ALKS 3831
ALKS 3831 is an investigational,
novel, once-daily, oral atypical antipsychotic drug candidate for
the treatment of adults with schizophrenia and for the treatment of
adults with bipolar I disorder. ALKS 3831 is composed of
samidorphan, a novel, new molecular entity, co-formulated with the
established antipsychotic agent, olanzapine, in a single bilayer
tablet.
About Schizophrenia
Schizophrenia is a serious brain disorder marked by positive
symptoms (hallucinations and delusions, disorganized speech and
thoughts, and agitated or repeated movements) and negative symptoms
(depression, blunted emotions and social
withdrawal).1 An estimated 2.4 million American
adults have schizophrenia,2 with men and women
affected equally.
About Bipolar I Disorder
Bipolar disorder is a brain
disorder that causes shifts in a person's mood, energy and ability
to function. Patients with this brain disorder may experience
debilitating mood shifts from extreme highs (mania) to extreme lows
(depression). Bipolar I disorder is characterized by the occurrence
of at least one manic episode, with or without the occurrence of a
major depressive episode, and affects approximately one percent of
the adult population in the United States in any given
year.3
About Alkermes plc
Alkermes plc is a fully
integrated, global biopharmaceutical company developing innovative
medicines in the fields of neuroscience and oncology. The company
has a portfolio of proprietary commercial products focused on
addiction and schizophrenia, and a pipeline of product candidates
in development for schizophrenia, bipolar I disorder,
neurodegenerative disorders and cancer. Headquartered
in Dublin, Ireland, Alkermes plc has an R&D
center in Waltham, Massachusetts; a research and manufacturing
facility in Athlone, Ireland; and a manufacturing facility
in Wilmington, Ohio. For more
information, please visit Alkermes' website
at www.alkermes.com.
Note Regarding Forward-Looking Statements
Certain
statements set forth in this press release constitute
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended, including,
but not limited to, statements concerning: the potential
therapeutic and commercial value of ALKS 3831 for the treatment of
adults with schizophrenia and the treatment of adults with bipolar
I disorder; the company's current expectations regarding the timing
and substance of the FDA's joint advisory committee meeting to
review the ALKS 3831 NDA, including the joint advisory committees'
consideration of the clinical meaningfulness of ALKS 3831's
attenuation of olanzapine-associated weight gain, including the
magnitude of weight effect and the impact of ALKS 3831 on
laboratory-based metabolic parameters, and potential clinical
risks related to the interaction of ALKS 3831 with opioids in
the intended patient populations; and the company's additional
expectations regarding the ALKS 3831 NDA, including
the FDA's PDUFA target action date for the NDA and the
adequacy of the data contained in the NDA to serve as the basis for
approval of ALKS 3831 for the treatment of adults with
schizophrenia and the treatment of adults with bipolar I disorder.
The company cautions that forward-looking statements are inherently
uncertain. Although the company believes that such statements are
based on reasonable assumptions within the bounds of its knowledge
of its business and operations, the forward-looking statements are
neither promises nor guarantees and they are necessarily subject to
a high degree of uncertainty and risk. Actual performance and
results may differ materially from those expressed or implied in
the forward-looking statements due to various risks and
uncertainties. These risks and uncertainties include, among others:
unanticipated impacts of the COVID-19 pandemic on the company's
operations, plans and prospects and on the operations of the
regulatory agencies involved in the review and potential approval
of ALKS 3831; potential changes in the cost, scope and duration of
the ALKS 3831 development and regulatory program; whether ALKS 3831
could be shown ineffective or unsafe during clinical studies; data
from the ALKS 3831 clinical development program may be interpreted
by the FDA in different ways than the company interprets it; the
FDA may not agree with the company's regulatory approval strategies
or components of its NDA filing for ALKS 3831, including the
company's clinical trial designs, conduct and methodologies,
manufacturing processes and facilities; the FDA's determination as
to the clinical meaningfulness of the ALKS 3831 weight data,
including the effects of ALKS 3831 on metabolic parameters; the
joint advisory committees' or FDA's views of impact on the
risk/benefit profile of ALKS 3831 of the interaction of ALKS 3831
with opioids in the intended patient populations; and the adequacy
of the preclinical and clinical results of the ALKS 3831 studies
and the PK bridging data and other information included in the ALKS
3831 NDA to meet the FDA's requirements for approval for
the proposed schizophrenia and bipolar I disorder indications; if
approved, whether ALKS 3831 will be commercialized successfully;
and those risks and uncertainties described under the heading "Risk
Factors" in the company's Annual Report on Form 10-K for the year
ended Dec. 31, 2019, the company's
Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 and in subsequent filings made by
the company with the U.S. Securities and Exchange Commission
("SEC"), which are available on the SEC's website at www.sec.gov.
Existing and prospective investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof. Except as required by law, the company
disclaims any intention or responsibility for updating or revising
any forward-looking statements contained in this press release.
1American Psychiatric Association. Schizophrenia
Spectrum and Other Psychiatric Disorders. Diagnostic and
Statistical Manual of Mental
Disorders. 5th ed. Washington,
DC: American Psychiatric Publishing; 2013.
2 National Institutes of
Health. Schizophrenia. Accessed on Aug. 20,
2020 from https://archives.nih.gov/asites/report/09-09-2019/report.nih.gov/nihfactsheets/Pdfs/Schizophrenia(NIMH).pdf.
3 Merikangas et al. Lifetime and 12-Month
Prevalence of Bipolar Spectrum Disorder in the National Comorbidity
Survey Replication. Arch Gen Psychiatry, 2007 May;
64(5):
543–552. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1931566/
Alkermes
Contacts:
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For
Investors:
|
Sandy
Coombs
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+1 781 609
6377
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For Media:
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Eva
Stroynowski
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+1 781 609
6823
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SOURCE Alkermes plc