DUBLIN, Oct. 7, 2020 /PRNewswire/ -- Alkermes
plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug
Administration (FDA) has posted on its website briefing documents
for the Oct. 9, 2020 joint meeting of
the Psychopharmacologic Drugs Advisory Committee and the Drug
Safety and Risk Management Advisory Committee 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 for 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 on Friday, Oct. 9, 2020. Both Alkermes and the FDA
have prepared pre-recorded presentations, which will be viewed by
the joint advisory committee prior to the meeting and will not be
replayed during the meeting. The briefing materials, including the
pre-recorded presentation slides and transcripts, are now posted to
the FDA website and can be accessed here:
https://www.fda.gov/advisory-committees/advisory-committee-calendar/updated-time-agenda-and-meeting-materials-october-9-2020-joint-meeting-psychopharmacologic-drugs.
The FDA has also established a docket for public comment on this
meeting. The docket number is FDA-2020-N-1767 and can be
accessed here:
https://beta.regulations.gov/document/FDA-2020-N-1767-0001/comment.
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; 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; 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. 6,
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
Logo -
https://mma.prnewswire.com/media/616416/Alkermes_plc_Logo.jpg