TITUSVILLE, N.J., Aug. 16, 2016 /PRNewswire/ -- Janssen
Research & Development, LLC, one of the Janssen Pharmaceutical
Companies of Johnson & Johnson, announced today that the U.S.
Food and Drug Administration (FDA) has granted a Breakthrough
Therapy Designation for esketamine, an investigational
antidepressant medication, for the indication of major depressive
disorder with imminent risk for suicide. If approved by the FDA,
esketamine would be one of the first new approaches to treat major
depressive disorder available to patients in the last 50 years.
This also marks the second time esketamine has received a
Breakthrough Therapy Designation from the U.S. regulatory
authority. Esketamine was first granted this designation for
treatment-resistant depression in November
2013. Breakthrough Therapy Designation is intended to
expedite development and review timelines when preliminary clinical
evidence indicates the drug may demonstrate substantial improvement
on one or more clinically significant endpoints over available
therapies for serious or life-threatening
conditions.1
The esketamine Phase 2 clinical trial data presented by Janssen
in May 2016 at the Society of
Biological Psychiatry 71st Annual Scientific Meeting in
Atlanta, Georgia, provided
preliminary clinical evidence to support the Breakthrough Therapy
Designation for major depressive disorder with imminent risk for
suicide.2
"In the U.S. alone, there are more than 41,000 suicides each
year,3 many of which result from untreated or poorly
treated major depression," said Husseini K.
Manji, MD, Global Head, Neuroscience Therapeutic Area,
Janssen. "This designation reinforces the potential of esketamine
as a novel treatment for patients with major depressive disorder
who are at imminent risk for suicide, a condition for which there
currently is no approved treatment and which represents a major
public health challenge. We are currently conducting clinical
trials to further evaluate the clinical benefit of esketamine and
look forward to working closely with the FDA throughout the
development and review process to bring this important potential
new therapy to patients in critical need."
About Esketamine
Esketamine for
intranasal administration is an investigational compound being
studied by Janssen as part of a global development program.
Esketamine is a non-competitive and subtype non-selective
activity-dependent N-methyl-D-aspartate (NMDA) receptor antagonist,
which has a novel mechanism of action, meaning it works differently
than currently available therapies for depression. The program in
treatment-resistant depression is currently in Phase 3, with six
ongoing clinical trials.
About Major Depressive Disorder
Major
depressive disorder affects approximately 16 million people in the
U.S.4 and 121 million people worldwide. Individuals with
depression, including major depressive disorder, experience
continuous suffering from a serious, biologically based disease
which can prevent them from enjoying life and functioning
normally.5 Depression is the psychiatric disorder most
commonly associated with suicide.6 In the U.S. alone,
there are more than 41,000 suicides each year,3 many of
which result from untreated or poorly treated major depression.
Only 30 percent of patients on currently available antidepressants
achieve remission.7 While conventional antidepressants
can be effective in treating major depressive disorder, and thereby
suicidal ideation, they are not FDA-approved for this use, and
their delayed onset of effect, which takes three to six weeks,
limits their value in treating acutely suicidal patients.
About the Janssen Pharmaceutical Companies
At
the Janssen Pharmaceutical Companies of Johnson & Johnson, we
are working to create a world without disease. Transforming lives
by finding new and better ways to prevent, intercept, treat and
cure disease inspires us. We bring together the best minds and
pursue the most promising science. We are Janssen. We collaborate
with the world for the health of everyone in it. Learn more at
www.janssen.com. Follow us at www.twitter.com/JanssenUS and
www.twitter.com/JanssenGlobal.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding product development and the potential benefits of
esketamine. The reader is cautioned not to rely on these
forward-looking statements. These statements are based on current
expectations of future events. If underlying assumptions prove
inaccurate or known or unknown risks or uncertainties materialize,
actual results could vary materially from the expectations and
projections of Janssen Research & Development, LLC and/or
Johnson & Johnson. Risks and uncertainties include, but are not
limited to: challenges and uncertainties inherent in product
research and development, including the uncertainty of clinical
success and of obtaining regulatory approvals; uncertainty of
commercial success; competition, including technological advances,
new products and patents attained by competitors; challenges to
patents; manufacturing difficulties and delays; changes in behavior
and spending patterns or financial distress of purchasers of health
care products and services; changes to applicable laws and
regulations, including global health care reforms; and trends
toward health care cost containment. A further list and description
of these risks, uncertainties and other factors can be found in
Johnson & Johnson's Annual Report on Form 10-K for the fiscal
year ended January 3, 2016, including
in Exhibit 99 thereto, and the company's subsequent filings with
the Securities and Exchange Commission. Copies of these filings are
available online at www.sec.gov, www.jnj.com or on request from
Johnson & Johnson. None of the Janssen Pharmaceutical Companies
or Johnson & Johnson undertakes to update any forward-looking
statement as a result of new information or future events or
developments.
- The U.S. Food and Drug Administration. "Expedited Programs for
Serious Conditions." Available at:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf.
Accessed August 2016.
- Canuso C, et al. "Esketamine for the Rapid Reduction of the
Symptoms of Major Depressive Disorder, Including Suicidal Ideation,
in Subjects Assessed to be at Imminent Risk for Suicide." Society
of Biological Psychiatry 71st Annual Scientific Meeting.
May 12-14, 2016.
- Centers for Disease Control and Prevention. National Center for
Health Statistics. "Suicide and Self-inflicted Injury." Available
at: http://www.cdc.gov/nchs/fastats/suicide.htm. Accessed
August 2016.
- National Institute of Mental Health. Major Depression Among
Adults. Available at:
http://www.nimh.nih.gov/health/statistics/prevalence/major-depression-among-adults.shtml.
Accessed August 2016.
- World Health Organization. Depression. Available at:
http://www.who.int/mediacentre/factsheets/fs369/en/. Accessed
August 2016.
- American Association of Suicidology. Depression and Suicide
Risk. Available at:
http://www.suicidology.org/portals/14/docs/resources/factsheets/2011/depressionsuicide2014.pdf.
Accessed August 2016.
- National Institute of Mental Health. Sequenced Treatment
Alternatives to Relieve Depression (STAR*D) Study. Available at:
http://www.nimh.nih.gov/about/director/2011/antidepressants-a-complicated-picture.shtml#_edn2.
Accessed August 2016.
Media Contact:
Greg Panico
609-730-3061 (office)
908-240-2011 (mobile)
Investor Contacts:
Joseph J.
Wolk
732-524-1142 (office)
Lesley Fishman
732-524-3922 (office)
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SOURCE Janssen Pharmaceutical Companies