DUBLIN, Oct. 9, 2020 /PRNewswire/ -- Alkermes
plc (Nasdaq: ALKS) today announced positive voting outcomes
from the joint meeting of the Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and Risk Management
Advisory Committee, appointed by the U.S. Food and Drug
Administration (FDA). The committees met to discuss ALKS 3831
(olanzapine/samidorphan), 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 committees jointly voted that samidorphan
meaningfully mitigates olanzapine-associated weight gain (16 yes, 1
no) and that the safety profile of ALKS 3831 has been adequately
characterized (13 yes, 3 no, 1 abstention).
"The favorable outcome of today's joint advisory
committee meeting represents an important milestone for the
patients, clinicians and families who may benefit from new
medicines for the treatment of schizophrenia and bipolar I
disorder. The personal testimonies shared during today's open
public hearing reinforced the need for treatment approaches that
consider patients' overall mental and physical health," said
Craig Hopkinson, M.D., Chief Medical
Officer and Executive Vice President of Research & Development
at Alkermes. "The ALKS 3831 development program is part of our
ongoing commitment to develop new therapeutic options for adults
living with serious mental illness. Today's outcome marks an
important step for this program and we look forward to working
with the FDA as it completes its review of the ALKS 3831
New Drug Application."
In addition, the committees jointly voted that labeling is
sufficient to mitigate the risks related to the opioid antagonist
action of samidorphan (11 yes, 6 no). Alkermes' proposed
labeling contraindicates the use of ALKS 3831 in patients who are
opioid-dependent or chronically using opioids, and the company has
proposed a comprehensive education plan, which includes
dissemination of information to potential prescribers and
pharmacists.
The joint advisory committee's recommendations, while
not binding, will be considered by the FDA in its review of the
ALKS 3831 New Drug Application (NDA). The Prescription Drug
User Fee Act (PDUFA) target action date for the ALKS 3831 NDA
is Nov. 15, 2020.
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.
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. Individuals 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; and the company's expectations regarding the FDA's
review of the ALKS 3831 NDA, including the company's interactions
with the FDA, 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: data from the ALKS 3831 clinical development
program may be interpreted by the FDA in different ways than the
company or the advisory committee interprets it; the FDA may not
agree with the company's regulatory approval strategy or components
of the ALKS 3831 NDA , 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 FDA's views of the
impact on the risk/benefit profile of ALKS 3831 of potential
interactions of ALKS 3831 with opioids in the intended patient
populations; the FDA's view of the adequacy and sufficiency 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;
unanticipated impacts of the COVID-19 pandemic on the operations of
the company, the FDA or other 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; 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 Oct. 7,
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:
For Investors: Sandy Coombs, +1 781 609 6377
For Media: Marisa
Borgasano, +1 781 609 6659
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SOURCE Alkermes plc