–– Once-Daily ALKS 5461 Significantly Improved
Depression Scores in Patients With Inadequate Response to Standard
Antidepressant Therapies ––
–– Company to Request Meeting with FDA to
Discuss Next Steps for Potential Regulatory Submission ––
–– Management to Hold Conference Call Today at
5:00 p.m. EDT ––
Alkermes plc (NASDAQ: ALKS) today announced positive topline
results from FORWARD-5, the third phase 3 efficacy study to read
out from the FORWARD pivotal program for ALKS 5461, a once-daily,
oral investigational medicine with a novel mechanism of action for
the adjunctive treatment of major depressive disorder (MDD) in
patients with an inadequate response to standard antidepressant
therapies. The study met its prespecified primary endpoint showing
treatment with ALKS 5461 significantly reduced symptoms of
depression in patients with MDD compared to placebo. ALKS 5461 was
generally well tolerated. The most common adverse events observed
for ALKS 5461 were nausea, dizziness and fatigue. Based on these
results, along with the substantial data collected to date on the
efficacy and safety of ALKS 5461 for the treatment of MDD, the
company plans to request a meeting with the U.S. Food and Drug
Administration’s (FDA) Division of Psychiatric Products to discuss
the filing strategy for this Fast Track designated medicine.
“We designed ALKS 5461 to have a novel mechanism of action for
the treatment of MDD, a serious disease where new therapeutic
options are highly sought after as millions of patients in the U.S.
do not respond to standard courses of antidepressant therapy,” said
Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “With the
successful completion of the FORWARD-5 study and data from more
than 1,500 patients to date, we have established a strong
foundation of evidence of ALKS 5461’s clinical utility in the
adjunctive treatment of major depressive disorder. With these data
now in hand, we will move forward rapidly to meet with
the FDA to determine the appropriate next steps toward a
regulatory submission for ALKS 5461, with a goal of bringing this
important new medication to patients with MDD.”
“ALKS 5461 embodies our dedication to developing novel and safe
CNS medicines that address compelling unmet needs faced by large
numbers of patients,” said Richard Pops, Chief Executive Officer of
Alkermes. “Major depressive disorder affects millions of people and
their families, and represents one of the greatest burdens of
suffering and cost of any disease today. New drug development in
the field is challenging and we are excited to advance ALKS 5461 in
this important indication.”
In the study, ALKS 5461 2mg/2mg met the prespecified primary
endpoint of significantly reducing depression scores compared to
placebo, as measured by 6-item Montgomery–Åsberg Depression Rating
Scale (MADRS-6) scores (p=0.018). ALKS 5461 2mg/2mg also
demonstrated statistically significant reductions in 10-item MADRS
(MADRS-10) scores compared to placebo (p=0.026). The 1mg/1mg dose
of ALKS 5461 showed improvement in depressive symptoms in the
study, but did not separate significantly from placebo.
The most commonly reported adverse events for ALKS 5461 in the
FORWARD-5 study were nausea, dizziness and fatigue. These findings
are consistent with those observed in previously reported studies
of ALKS 5461. Alkermes will present comprehensive data from
FORWARD-5 at an upcoming medical meeting and submit the results for
publication in a peer-reviewed journal.
About the FORWARD-5
StudyFORWARD-5 was a phase 3, randomized, double-blind,
multicenter, placebo-controlled, sequential parallel comparison
design (SPCD) study that evaluated the safety, tolerability and
efficacy of two dose levels of ALKS 5461 (2mg/2mg and 1mg/1mg) as
adjunctive treatment in patients with MDD who had an inadequate
response to a stable dose of either a selective serotonin reuptake
inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor
(SNRI). The study randomized 407 subjects.
The study was conducted in two sequential stages: Stage 1 was 5
weeks in duration, Stage 2 was 6 weeks. In Stage 1, the average
change from baseline depression scores was calculated for weeks 3
through 5. For Stage 2, the average change was calculated for weeks
3 through 6. The results of Stages 1 and 2 were then averaged.
Depression scores were assessed using the 6-item Montgomery–Åsberg
Depression Rating Scale (MADRS-6) and MADRS-10. MADRS-6, a subscale
of the MADRS-10 assessment tool for depression, focuses on the core
symptoms of depression.
About the FORWARD Clinical
ProgramThe FORWARD
(Focused On Results With A Rethinking
of Depression) pivotal program for ALKS 5461 includes
three core phase 3 efficacy studies, as well as additional
supportive studies to evaluate the long-term safety, dosing,
pharmacokinetic profile and human abuse potential of ALKS 5461.
FORWARD-5 is the third phase 3 efficacy study to read out from the
FORWARD program. Results from FORWARD-3 and FORWARD-4 were
announced in January 2016 and detailed data were presented at the
American Society of Clinical Psychopharmacology (ASCP) in June
2016.
Conference CallAlkermes will
host a conference call on Thursday, Oct. 20, 2016 at 5:00 p.m. EDT
(10:00 p.m. BST). The conference call may be accessed by dialing +1
888 424 8151 for U.S. callers and +1 847 585 4422 for international
callers. The conference call ID number is 6037988. The conference
call will also be webcast on the Investors section of Alkermes’
website at www.alkermes.com. In addition, a replay of the
conference call will be available from 8:00 p.m. EDT on Thursday,
Oct. 20, 2016 (1:00 a.m. BST, Friday, Oct. 21), through 5:00 p.m.
EDT (10:00 p.m. BST) on Thursday, Oct. 27, 2016, and may be
accessed by visiting Alkermes’ website or by dialing +1 888 843
7419 for U.S. callers and +1 630 652 3042 for international
callers. The replay access code is 6037988.
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 treating 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 AlkermesAlkermes
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, development and regulatory plans, and commercial
potential of 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 projected or suggested 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 in Item 1A under the heading “Risk Factors” in the
company’s Annual Report on Form 10-K for the fiscal year ended Dec.
31, 2015, and in any other 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
they are made. The information contained in this press release is
provided by the company as of the date hereof, and, except as
required by law, the company disclaims any intention or
responsibility for updating or revising any forward-looking
information contained in this press release.
DSM-5® is a registered trademark of the American Psychiatric
Association.
1 Kessler RC, Chiu WT, Demler O, Walters EE. Prevalence,
severity, and comorbidity of twelve-month DSM-IV disorders in the
National Comorbidity Survey Replication (NCS-R). Archives of
General Psychiatry, 2005 Jun; 62 (6): 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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Alkermes plcFor Investors:Eva Stroynowski, +1
781-609-6823orSandy Coombs, +1 781-609-6377orFor Media:Jennifer
Snyder, +1 781-609-6166
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