Treatment with once-daily
EFFEXOR® met primary and all secondary efficacy
endpoints in outpatient adults with GAD
EFFEXOR® was generally well
tolerated, consistent with its known safety profile
Pharmaceuticals and Medical Devices Agency
(PMDA) submission targeted for 2025
PITTSBURGH and TOKYO, Oct. 9, 2024
/PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare
company, today announced positive top-line results of its Phase 3
study (B2411367) in Japan
evaluating the safety and efficacy of EFFEXOR®
(venlafaxine) in adults with generalized anxiety disorder
(GAD).
The study achieved its primary objective of superiority of
anxiolytic effects of venlafaxine compared to placebo at 8 weeks,
based on the change in the Hamilton Anxiety Rating Scale (HAM-A)
total score from baseline (two-sided p-value=0.012). All seven
secondary efficacy endpoints as defined by the trial protocol were
met, which confirmed superiority compared to placebo.
In this study, EFFEXOR® was generally well tolerated
with a profile consistent with its known safety profile in
non-Japanese patients. In particular:
- Low discontinuation rates due to treatment emergent adverse
events (TEAEs) were seen (7.3% vs 1.7% in placebo) with 3.9% vs
0.6% assessed as related to treatment.
- No serious TEAEs or TEAEs with severe intensity were observed
(0% vs 1.1% and 0.6%, respectively, in placebo).
- Incidence of new suicidal ideation was lower in the
EFFEXOR® treatment group than in placebo (2.8% vs
5.1%).
- Commonly observed TEAEs like nausea and somnolence were
reported at a lower rate than outside of Japan.
"We are very pleased with these top-line results, which
consistently demonstrate the efficacy and safety of
EFFEXOR® for the treatment of generalized anxiety
disorder in Japanese patients with moderate to severe disease. The
benefit-risk profile observed with EFFEXOR® in this
study underscores its potential as a meaningful treatment option
for patients with GAD in Japan, a
condition which currently does not have any approved treatments
available," said Viatris Chief R&D Officer Philippe Martin. "This significant life cycle
opportunity is yet another proof point of our diversified base
business pipeline, which includes more than 70 novel products in
development or under regulatory review. Our focused execution of
this robust pipeline gives us confidence in our ability to continue
to grow our base business and address unmet medical needs."
"Despite generalized anxiety disorder being well-recognized
globally, there is a large, general public awareness gap of GAD in
Japan. Exacerbating this gap, is
the absence of national clinical practice guidelines for treating
the disease, signaling a large unmet need in Japan for those living with and treating
excessive anxiety and worry," said Sun-A Kim, Country Manager of
Viatris Japan. "Viatris Japan remains committed to meeting the
needs of patients living with mental health disorders, and we are
pleased to see that the results from this study signal the
potential of EFFEXOR® to further reach patients as a
possible treatment of GAD, for which there are currently no
approved therapies in Japan."
Outside of Japan, selective
serotonin reuptake inhibitors (SSRIs) and serotonin–norepinephrine
reuptake inhibitors (SNRIs) are recommended as first-line drug
therapies for patients diagnosed with GAD. EFFEXOR® is
currently approved in Japan for
the indication of major depressive disorder in adults.
EFFEXOR® has also been approved for the indication of
GAD in more than 80 countries outside of Japan.
The Company expects to present the full results from this Phase
3 study at a future medical congress.
About Phase 3 Study B2411367
The study was a
randomized, double-blind, placebo-controlled, multicenter Phase 3
study that was conducted in Japan
to evaluate the efficacy and safety of venlafaxine in 357 Japanese
outpatients with GAD based on the Diagnostic and Statistical Manual
of Mental Disorders (DSM)-5 diagnostic criteria and assessed with a
Hamilton Anxiety Rating Scale (HAM-A) total score ≥ 20.
Patients were randomized equally to a flexible dose of 75-225
mg/day venlafaxine or placebo (once-daily, oral dosing) for an
8-week treatment period. The primary objective of the study was to
show superiority over placebo in terms of the anxiolytic effects of
venlafaxine, based on the change in the HAM-A total score from
baseline at 8 weeks. The secondary objective was to evaluate the
safety and tolerability of venlafaxine.
Key secondary endpoints were defined as absolute score/change
from baseline at 8 weeks in:
- HAM-A psychic anxiety factor
- HAM-A somatic anxiety factor
- Clinical Global Impressions-Severity of Illness (CGI-S)
- Clinical Global Impressions-Global Improvement (CGI-I)
- Generalized Anxiety Disorder 7 (GAD-7)
- Zung Self-Rating Anxiety Scale (ZSRAS)
- Sheehan Disability Scale (SDISS)
Viatris is also conducting an open-label, multicenter, long-term
extension (over 52 weeks) study to evaluate the safety and efficacy
of venlafaxine in Japanese outpatients with GAD who completed study
B2411367. Results from this study are scheduled to be delivered in
2025.
About Generalized Anxiety Disorder (GAD)
GAD is
defined by the World Health Organization as persistent and
excessive worry about daily activities or events. An estimated 4%
of the global population currently experience an anxiety
disorder.1 GAD is among the most prevalent and highly
disabling mental health conditions that negatively impacts
patient's quality of life and disrupts activities of daily
living.2
About Viatris
Viatris Inc. (NASDAQ: VTRS) is a global healthcare company uniquely
positioned to bridge the traditional divide between generics and
brands, combining the best of both to more holistically address
healthcare needs globally. With a mission to empower people
worldwide to live healthier at every stage of life, we provide
access at scale, currently supplying high-quality medicines to
approximately 1 billion patients around the world annually and
touching all of life's moments, from birth to the end of life,
acute conditions to chronic diseases. With our exceptionally
extensive and diverse portfolio of medicines, a one-of-a-kind
global supply chain designed to reach more people when and where
they need them, and the scientific expertise to address some of the
world's most enduring health challenges, access takes on deep
meaning at Viatris. We are headquartered in the U.S., with global
centers in Pittsburgh,
Shanghai and Hyderabad, India. Learn more at viatris.com
and investor.viatris.com, and connect with us on LinkedIn,
Instagram, YouTube and X (formerly Twitter).
Forward-Looking Statements
This press release includes
statements that constitute "forward-looking statements." These
statements are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Such forward
looking statements may include statements regarding the outcomes of
clinical trials; positive top-line results of its Phase 3 study
(B2411367) in Japan evaluating the
safety and efficacy of EFFEXOR® (venlafaxine) in adults
with generalized anxiety disorder (GAD); Pharmaceuticals and
Medical Devices Agency (PMDA) submission targeted for 2025; the
benefit-risk profile observed with EFFEXOR® in this
study underscores its potential as a meaningful treatment option
for patients with GAD in Japan, a
condition which currently does not have any approved treatments
available; this significant life cycle opportunity is yet another
proof point of our diversified base business pipeline, which
includes more than 70 novel products in development or under
regulatory review; our focused execution of this robust pipeline
gives us confidence in our ability to continue to grow our base
business and address unmet medical needs; the Company expects to
present the full results from this Phase 3 study at a future
medical congress; Viatris is also conducting an open-label,
multicenter, long-term extension (over 52 weeks) study to evaluate
the safety and efficacy of venlafaxine in Japanese outpatients with
generalized anxiety disorder who completed study B2411367 and
results from this study are scheduled to be delivered in 2025.
Because forward-looking statements inherently involve risks and
uncertainties, actual future results may differ materially from
those expressed or implied by such forward-looking statements.
Factors that could cause or contribute to such differences include,
but are not limited to: actions and decisions of healthcare and
pharmaceutical regulators; changes in healthcare and pharmaceutical
laws and regulations in the U.S. and abroad; any regulatory, legal
or other impediments to Viatris' ability to bring new products to
market, including but not limited to "at-risk" launches; Viatris'
or its partners' ability to develop, manufacture, and commercialize
products; the scope, timing and outcome of any ongoing legal
proceedings, and the impact of any such proceedings; the
possibility that Viatris may be unable to realize the intended
benefits of, or achieve the intended goals or outlooks with respect
to, its strategic initiatives; the possibility that Viatris may be
unable to achieve intended or expected benefits, goals, outlooks,
synergies, growth opportunities and operating efficiencies in
connection with divestitures, acquisitions, other transactions or
restructuring programs, within the expected timeframes or at all;
goodwill or impairment charges or other losses related to the
divestiture or sale of businesses or assets; Viatris' failure to
achieve expected or targeted future financial and operating
performance and results; the potential impact of public health
outbreaks, epidemics and pandemics; any significant breach of data
security or data privacy or disruptions to our information
technology systems; risks associated with international operations;
the ability to protect intellectual property and preserve
intellectual property rights; changes in third-party relationships;
the effect of any changes in Viatris' or its partners' customer and
supplier relationships and customer purchasing patterns; the
impacts of competition; changes in the economic and financial
conditions of Viatris or its partners; uncertainties and matters
beyond the control of management, including general economic
conditions, inflation and exchange rates; failure to execute stock
repurchases consistent with current expectations; stock price
volatility; and the other risks described in Viatris' filings with
the Securities and Exchange Commission (SEC). Viatris routinely
uses its website as a means of disclosing material information to
the public in a broad, non-exclusionary manner for purposes of the
SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no
obligation to update these statements for revisions or changes
after the date of this press release other than as required by
law.
References
- World Health Organization. Anxiety Disorders Fact Sheet.
27 Sept. 2023,
www.who.int/news-room/fact-sheets/detail/anxiety-disorders.
- Matsuyama S, Otsubo T, Nomoto K, Higa S, Takashio O. Prevalence
of Generalized Anxiety Disorder in Japan: A General Population Survey.
Neuropsychiatr Dis Treat. 2024;20:1355-1366.
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