DUBLIN, Aug. 17, 2020 /PRNewswire/ -- Alkermes plc
(Nasdaq: ALKS) today announced the publication of results from the
phase 3 ENLIGHTEN-2 clinical trial of ALKS 3831
(olanzapine/samidorphan) in the peer-reviewed publication,
American Journal of Psychiatry. ENLIGHTEN-2 was a six-month
study evaluating the weight gain profile of ALKS 3831 compared to
olanzapine in 561 patients with stable schizophrenia. Positive
topline data from the ENLIGHTEN-2 study were first reported in
November 2018.
The full manuscript, titled "Effects of Olanzapine Combined With
Samidorphan on Weight Gain in Schizophrenia: A 24-Week Phase 3
Study," is now accessible online. External publication authors
include: René Kahn, M.D., Ph.D., Icahn School of Medicine at Mount
Sinai (corresponding author); Christoph
Correll, M.D., Barbara and Donald
Zucker School of Medicine at Hofstra/Northwell; and John
Newcomer, M.D., Washington
University School of Medicine in St. Louis.
"The publication of the ENLIGHTEN-2 data in a peer-reviewed
journal represents an important milestone for the ALKS 3831
development program and demonstrates Alkermes' dedication to
expanding the body of research on schizophrenia treatment," said
Craig Hopkinson, M.D., Executive
Vice President, Research & Development and Chief Medical
Officer at Alkermes. "Alkermes remains committed to developing and
bringing to market potential new medicines that may help people
living with serious mental illness and their families."
ENLIGHTEN-2 is the second of two key studies included in the
ALKS 3831 ENLIGHTEN clinical development program. ENLIGHTEN-1, the
first phase 3 study, evaluated the efficacy, safety and
tolerability of ALKS 3831 compared to placebo in patients
experiencing an acute exacerbation of schizophrenia. Positive
topline data from the ENLIGHTEN-1 study were first reported in
June 2017 and full results were later
published in the peer-reviewed publication, Journal of Clinical
Psychiatry.1
A New Drug Application (NDA) for ALKS 3831 for the treatment of
adults with schizophrenia and the treatment of adults with bipolar
I disorder is currently under U.S. Food and Drug Administration
(FDA) review, with a Prescription Drug User Fee Act (PDUFA) target
action date of 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).2 An estimated 2.4
million American adults have schizophrenia,3 with men
and women affected equally.
About Bipolar I Disorder
Bipolar disorder is a
brain disorder that causes unusual 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.4
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 company's commitment
to developing and bringing to market new therapeutic options that
may help people living with serious mental illness and their
families; 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 expected
timing of the FDA's PDUFA target action date for the NDA for
ALKS 3831. 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 business operations, plans and prospects;
whether the preclinical and clinical results of the ALKS 3831
studies and the PK bridging data contained in the NDA will meet the
regulatory requirements for approval by the FDA for the proposed
schizophrenia and bipolar I disorder indications; 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; whether the NDA for ALKS 3831 will
be approved by the FDA and, 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.
1 Potkin et al. Efficacy and Safety of a
Combination of Olanzapine and Samidorphan in Adult Patients With an
Acute Exacerbation of Schizophrenia: Outcomes From the Randomized,
Phase 3 ENLIGHTEN-1 Study. J Clin Psych,
2020;81(2):19m12769. https://doi.org/10.4088/JCP.19m12769
2American Psychiatric Association. Schizophrenia
Spectrum and Other Psychiatric Disorders. Diagnostic and
Statistical Manual of Mental Disorders. 5th ed. Washington, DC: American Psychiatric
Publishing; 2013.
3 National Institutes of Health.
Schizophrenia. Accessed on August 14,
2020 from
https://archives.nih.gov/asites/report/09-09-2019/report.nih.gov/nihfactsheets/Pdfs/Schizophrenia(NIMH).pdf.
4 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
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