Alkermes Announces Initiation of Study 217 for ALKS 5461 for Treatment of Major Depressive Disorder
June 12 2017 - 7:00AM
Business Wire
— Phase 3b Study Designed to Further Evaluate
ALKS 5461’s Potential Benefits on Mood Domains Regulated by
Endogenous Opioid Modulation —
— Company Reiterates Plans to Submit New Drug
Application to FDA by Year-End 2017 —
Alkermes plc (NASDAQ: ALKS) today announced the initiation of
study 217, a phase 3b trial of ALKS 5461, a once-daily, oral
investigational medicine with a novel mechanism of action for the
adjunctive treatment of major depressive disorder (MDD). The study
will evaluate the efficacy and safety of ALKS 5461 in patients
suffering from MDD who have had an inadequate response to commonly
prescribed drugs for depression, including selective serotonin
reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake
inhibitors (SNRIs). In addition to the traditional
Montgomery–Åsberg Depression Rating Scale (MADRS) for assessing
improvement in depression symptoms, study 217 will include scales
to further evaluate ALKS 5461’s potential benefits on mood and
associated behavioral domains known to be regulated by endogenous
opioid modulation. The company also reiterated plans to submit a
New Drug Application (NDA) for ALKS 5461 for the adjunctive
treatment of MDD to the U.S. Food and Drug Administration (FDA) by
year-end 2017.
“Opioid modulation represents a new mechanism for the treatment
of depression that may provide benefits beyond those observed with
traditional antidepressants. Along with the clinical community, we
are looking forward to further exploring ALKS 5461’s potential in
regulating domains such as social connection, resilience and
anhedonia. Study 217 includes scales and endpoints to help
elucidate ALKS 5461’s potential effects on these specific mood
domains where opioid modulation may yield singular benefit,”
stated Elliot Ehrich, M.D., Executive Vice President, Research
and Development of Alkermes. “In parallel, we plan to meet with the
FDA in July for our scheduled pre-NDA meeting and are preparing our
New Drug Application for ALKS 5461 for the adjunctive treatment of
MDD.”
Study 217 is a phase 3b, multinational, randomized,
double-blind, placebo-controlled clinical trial that will evaluate
the efficacy, safety and tolerability of ALKS 5461 as adjunctive
treatment in patients with MDD. The 11-week, 2-stage study will
randomize up to 325 patients and incorporates design features
informed by the FORWARD pivotal program to help ensure rigorous
patient selection, monitoring and evaluation. The primary objective
of the study is to assess ALKS 5461’s ability to improve depressive
symptoms, as measured by MADRS-6 and MADRS-10. Specific scales to
evaluate additional potential benefits of ALKS 5461 included in
study 217 are the Connor-Davidson Resilience Scale (CD-RISC),
Snaith-Hamilton Pleasure Scale (SHAPS), Quality of Life Enjoyment
and Satisfaction Questionnaire-Short Form, Brief Pain
Inventory-Short Form (BPI-SF), and the Clinical Global
Impression-Severity (CGI-S) and Clinical Global
Impression-Improvement (CGI-I) scales.
About ALKS 5461ALKS 5461 is
a proprietary, investigational, once-daily oral medicine that acts
as a balanced neuromodulator in the brain and represents a novel
mechanism of action for the adjunctive treatment of MDD. ALKS 5461
consists of samidorphan and buprenorphine, and is designed to
rebalance brain function that is dysregulated in the state of
depression. In October 2013, the FDA granted Fast Track status for
ALKS 5461 for the adjunctive treatment of MDD in patients with an
inadequate response to standard antidepressant therapies.
About MDDAccording to
the DSM-5® (Diagnostic and Statistical Manual of Mental
Disorders, Fifth Edition), major depressive disorder (MDD) is
a condition in which patients exhibit depressive symptoms, such as
a depressed mood or a loss of interest or pleasure in daily
activities consistently for at least a two-week period, and
demonstrate impaired social, occupational, educational or other
important functioning. An estimated 17 million people in the U.S.
suffer from MDD in a given year,1,2 the majority of whom may
not adequately respond to initial antidepressant therapy.3
About Alkermes plcAlkermes
plc is a fully integrated, global biopharmaceutical company
developing innovative medicines for the treatment of central
nervous system (CNS) diseases. The company has a diversified
commercial product portfolio and a substantial clinical pipeline of
product candidates for chronic diseases that include schizophrenia,
depression, addiction and multiple sclerosis. 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
StatementsCertain 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
therapeutic value and commercial potential of ALKS 5461, and the
development and regulatory plans and timelines, including the
timing of submission of the NDA, for ALKS 5461. You are cautioned
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: whether preclinical and
clinical results for ALKS 5461 will be predictive of future
clinical study results and commercial potential of ALKS 5461;
whether future clinical trials for ALKS 5461 will be completed on
time or at all; potential changes in cost, scope and duration of
the ALKS 5461 clinical development program; whether ALKS 5461 could
be shown ineffective or unsafe during clinical studies; whether the
preclinical and clinical results of ALKS 5461 will meet the
regulatory requirements for approval; whether regulatory
submissions may occur or be submitted in a timely manner; 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, 2016 and Quarterly Report on Form 10-Q for the quarter ended
Mar. 31, 2017 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.
DSM-5® is a registered trademark of the American
Psychiatric Association.
1 Kessler RC et al (2005) Archives of General Psychiatry,
Jun; 62 (6), pp. 617-27.2 U.S. Census.3 Rush AJ et al
(2007) Am J. Psychiatry, 163:11, pp. 1905-1917 (STAR*D
Study).
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