Market Overview

FDA Issues a Complete Response Letter for New Drug Application for Dasotraline for the Treatment of ADHD

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Sunovion
Pharmaceuticals Inc.
(Sunovion) today announced that the U.S. Food
and Drug Administration (FDA) issued a Complete Response Letter for the
New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine
and norepinephrine reuptake inhibitor (DNRI), for the treatment of
attention-deficit hyperactivity disorder (ADHD).

Upon completion of their review, the FDA determined that they cannot
approve the dasotraline NDA for the treatment of ADHD in its current
form. The Agency indicated that additional clinical data are needed to
further evaluate the efficacy and tolerability of dasotraline for the
treatment of ADHD. Sunovion plans to meet with the FDA to discuss their
comments and determine next steps.

Dasotraline was evaluated in approximately 2,500 children and adults
with ADHD in multiple placebo-controlled safety and efficacy studies,1,2,3,4
as well as two long-term safety studies.

"While we are disappointed with the FDA's decision, we remain confident
in the future of dasotraline," said Antony Loebel, M.D., Executive Vice
President and Chief Medical Officer at Sunovion, Head of Global Clinical
Development for Sumitomo Dainippon Pharma Group. "We plan to discuss
next steps for the dasotraline ADHD program with the FDA as soon as
possible."

Dasotraline is also being studied for the treatment of moderate to
severe binge eating disorder (BED) in adults in the U.S. Data from two
positive pivotal studies5,6 will support an expected
marketing application submission to the FDA for dasotraline to treat BED
in FY2018.

About Dasotraline

Dasotraline is a new chemical entity that acts as a dual dopamine and
norepinephrine reuptake inhibitor (DNRI). It has an extended half-life
(47-77 hours in adults; 58-84 hours in children) that supports the
potential for stable plasma concentrations yielding a continuous
therapeutic effect over the 24-hour dosing interval.

Dasotraline was discovered by Sunovion Pharmaceuticals Inc. and is
currently in development to evaluate its use in treating ADHD and BED.
It has not been approved by the FDA for the treatment of ADHD or BED.

About Attention-Deficit Hyperactivity Disorder (ADHD)

ADHD is a persistent pattern of inattention and/or
hyperactivity-impulsivity that interferes with functioning and
development, as characterized by inattention (e.g., distractibility,
forgetfulness) and/or hyperactivity and impulsivity (e.g., fidgeting,
restlessness).7 Approximately 11.0 percent of children 4 to
17 years of age have been diagnosed with ADHD in the U.S.8 Up
to 60.0 percent of children with ADHD continue to experience symptoms
into adulthood.9 It is estimated that 4.4 percent of adults
between ages 18 and 44 years experience some symptoms and disabilities
from ADHD in the U.S.10

In children, ADHD is associated with social rejection and reduced school
performance.11 Children with a history of ADHD are ten times
as likely to have difficulties with friendships and can have more
frequent and severe injuries than peers without ADHD.12 In
adults, symptoms reduce the quality of social or occupational
functioning.5 Studies have shown that ADHD is associated with
higher levels of unemployment, and those who are employed may experience
workplace impairment, reduced productivity and behavioral issues.13
Adults with ADHD are also at increased risk of trauma, workplace
injuries and traffic accidents, are more likely to be diagnosed with
comorbid mental health conditions and have a higher incidence of
separation and divorce.14,15,16

About Sunovion Pharmaceuticals Inc. (Sunovion)

Sunovion is a global biopharmaceutical company focused on the innovative
application of science and medicine to help people with serious medical
conditions. Sunovion's vision is to lead the way to a healthier world.
The company's spirit of innovation is driven by the conviction that
scientific excellence paired with meaningful advocacy and relevant
education can improve lives. With patients at the center of everything
it does, Sunovion has charted new paths to life-transforming treatments
that reflect ongoing investments in research and development and an
unwavering commitment to support people with psychiatric, neurological
and respiratory conditions.

Headquartered in Marlborough, Mass., Sunovion is an indirect,
wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion
Pharmaceuticals Europe Ltd., based in London, England, and Sunovion
Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are
wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc.
Additional information can be found on the company's websites: www.sunovion.com,
www.sunovion.eu and www.sunovion.ca.
Connect with Sunovion on TwitterLinkedInFacebook and YouTube.

About Sumitomo Dainippon Pharma Co., Ltd.

Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical
companies in Japan, operating globally in major pharmaceutical markets,
including Japan, the U.S., China and the European Union. Sumitomo
Dainippon Pharma aims to create innovative pharmaceutical products in
the Psychiatry & Neurology area, the Oncology area and Regenerative
medicine/Cell therapy field, which have been designated as the focus
therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in
2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo
Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than
6,000 employees worldwide. Additional information about Sumitomo
Dainippon Pharma is available through its corporate website at www.ds-pharma.com.

SUNOVION is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.

Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon
Pharma Co., Ltd.
© 2018 Sunovion Pharmaceuticals Inc.
All rights reserved.

 

For a copy of this release, visit Sunovion's web site at www.sunovion.com

 

References

1 Investigational drug dasotraline significantly
improved symptoms of attention deficit hyperactivity disorder (ADHD) in
a placebo-controlled study in adults. Sunovion Newsroom. December
11, 2014. Available at:
https://news.sunovion.com/press-release/investigational-drug-dasotraline-significantly-improved-symptoms-attention-deficit.
Accessed August 2018.

2 Sunovion announces
top-line results from studies evaluating dasotraline in adults with
binge eating disorder and attention deficit hyperactivity disorder.
Sunovion Newsroom. January 13, 2017. Available at:
https://news.sunovion.com/press-release/sunovion-announces-top-line-results-studies-evaluating-dasotraline-adults-binge.
Accessed August 2018.

3 Sunovion announces
results from pivotal study evaluating novel drug candidate dasotraline
in children with ADHD. Sunovion newsroom. September 20, 2016. Available
at:
https://news.sunovion.com/press-release/sunovion-announces-results-pivotal-study-evaluating-novel-drug-candidate-dasotraline.
Accessed August 2018.

4 Sunovion announces
positive results from pivotal study evaluating novel drug candidate
dasotraline in children with ADHD. Sunovion Newsroom. April 21, 2017.
Available at:
https://news.sunovion.com/press-release/sunovion-announces-positive-results-pivotal-study-evaluating-novel-drug-candidate.
Accessed August 2018.

5 Sunovion announces
top-line results from studies evaluating dasotraline in adults with
binge eating disorder and attention deficit hyperactivity disorder.
Sunovion Newsroom. January 13, 2017. Available at:
https://news.sunovion.com/press-release/sunovion-announces-top-line-results-studies-evaluating-dasotraline-adults-binge.
Accessed August 2018.

6 Sunovion announces
positive top-line results from pivotal study evaluating dasotraline in
adults with binge eating disorder. Sunovion Newsroom. July 25, 2018.
Available at:
https://news.sunovion.com/press-release/sunovion-announces-positive-top-line-results-pivotal-study-evaluating-dasotraline.
Accessed August 2018.

7 American Psychiatric
Association. Diagnostic and Statistical Manual of Mental Disorders.
Fifth Edition. Washington, DC: American Psychiatric Association, 2013.

8
Centers for Disease Control and Prevention.
Attention-Deficit/Hyperactivity Disorder (ADHD): Data and Statistics.
[Internet]. Available from:
http://www.cdc.gov/ncbddd/adhd/data.html.
Accessed March 2017.

9 Targum SD. & Adler LA.
Our Current Understanding of Adult ADHD. Innovations in Clinical
Neuroscience. 2014; 11(11-12): 30–35.

10
National Resource Center on ADHD. General Prevalence of ADHD [Internet].
Available from:
http://www.help4adhd.org/Understanding-ADHD/About-ADHD/Data-and-Statistics/General-Prevalence.aspx.
Accessed March 2017.

11 American Psychiatric
Association. Diagnostic and Statistical Manual of Mental Disorders.
Fifth Edition. Washington, DC: American Psychiatric Association, 2013.

12
Centers for Disease Control and Prevention. Attention-Deficit /
Hyperactivity Disorder (ADHD): Other Concerns & Conditions. [Internet].
Available from:
http://www.cdc.gov/ncbddd/adhd/conditions.html.
Accessed March 2017.

13 Küpper, T, Haavik, J,
Drexler, H, et al. The Negative Impact of
Attention-Deficit/Hyperactivity Disorder on Occupational Health in
Adults and Adolescents. International Archives of Occupational and
Environmental Health. 2012: 85(8), 837-47.

14
Assessing Adults with ADHD and Comorbidities. Primary Care Companion to
the Journal of Clinical Psychiatry. 2009;11(1): 25-43.

15
WebMD. Attention Deficit Hyperactivity Disorder in Adults [Internet].
Available from:
http://www.webmd.com/add-adhd/guide/adhd-adults?page=2#2.
Accessed March 2017.

16 Koblan, KS, Hopkins
SC, Sarma, K, et al. Assessment of Human Abuse Potential of Dasotraline
Compared to Methylphenidate and Placebo in Recreational Stimulant Users.
Drug Alcohol Dependence. 2015; 159: 26-34.

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