-- FDA Advisory Committee to Review New Drug Application for
ALKS 3831 for the Treatment of Adults with Schizophrenia or
Bipolar I Disorder --
DUBLIN, Oct. 9, 2020 /PRNewswire/ -- Alkermes plc
(Nasdaq: ALKS) today announced that Nasdaq has temporarily halted
trading of the company's ordinary shares.
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), will be held today to review the company's New Drug
Application (NDA) for ALKS 3831 (olanzapine/samidorphan). ALKS 3831
is an investigational, novel, once-daily, oral atypical
antipsychotic drug candidate for the treatment of adults with
schizophrenia and the treatment of adults with bipolar I
disorder.
The joint advisory committee meeting, which is being held
virtually, is scheduled to begin at 10:00
a.m. ET. The briefing materials and webcast information can
be found on the FDA website at:
https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-time-agenda-and-meeting-materials-october-9-2020-joint-meeting-psychopharmacologic-drugs
The Prescription Drug User Fee Act (PDUFA) target action date
for the ALKS 3831 NDA is Nov. 15,
2020.
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 PDUFA target action date for the ALKS 3831 NDA.
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 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; 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; 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; 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; 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. 8,
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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