Sunovion Announces Positive Results from Pivotal Study Evaluating Novel Drug Candidate Dasotraline in Children with ADHD
– In a classroom setting, dasotraline demonstrated significantly
improved ADHD symptoms in children six to 12 years of age up to 24 hours
after once-daily dosing –
– Full results presented at the 6th World
Congress on ADHD –
MARLBOROUGH, Mass.–(BUSINESS WIRE)–Sunovion
Pharmaceuticals Inc. (Sunovion) today announced positive results of
a pivotal Phase 3 study (SEP360-305) evaluating the efficacy and safety
of novel drug candidate dasotraline, a dopamine and norepinephrine
reuptake inhibitor (DNRI) being evaluated in children six to 12 years of
age with attention deficit hyperactivity disorder (ADHD). In a
laboratory classroom setting, dasotraline showed persistent,
statistically significant improvement in ADHD symptoms compared to
placebo throughout the day (12 to 24 hours post-dose), demonstrating a
duration of effect of up to 24 hours, and was generally well tolerated.1
The full study results were presented in a poster session today at the 6th
World Congress on ADHD, being held April 20-23, 2017, in Vancouver,
Canada.
“ADHD symptoms can have a significant impact on all aspects of a child’s
life, inside and outside of the classroom,” said Ann C. Childress, M.D.,
President of the Center for Psychiatry and Behavioral Medicine, Las
Vegas, Nevada. “Treatment options that provide sustained improvement in
ADHD symptoms throughout the day can have a profound effect on the lives
of children living with ADHD and their parents or caregivers.”
Sunovion plans to submit a New Drug Application (NDA) to the U.S. Food
and Drug Administration (FDA) in fiscal year 2017 (April 2017-March
2018) for the treatment of ADHD. Dasotraline is also being investigated
for the treatment of binge eating disorder (BED) in adults in the U.S.
“We are encouraged by these data showing the long-acting and robust
therapeutic benefits dasotraline may provide children with ADHD,” said
Antony Loebel, M.D., Executive Vice President and Chief Medical Officer
at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon
Pharma Group. “These results add to our body of knowledge about
dasotraline and reinforce its potential as a treatment option poised to
address significant gaps in available treatment.”
Results from SEP360-305 pivotal study
In this study, children six to 12 years of age with ADHD taking
dasotraline 4 mg/day experienced statistically significant and
clinically meaningful improvement compared to placebo on the primary
endpoint, change from baseline at Day 15 in ADHD symptoms as measured by
mean Swanson, Kotkin, Agler, M-Flynn and Pelham Scale Combined Score
(SKAMP-CS) obtained from an average of seven assessments collected over
the 12-hour classroom day, 12 to 24 hours post-dose (least squares [LS]
mean change from baseline at Day 15: -3.19 [95% CI: -5.06, -1.32] vs
1.99 [0.11, 3.88], respectively; effect size (ES) = 0.85, p<0.0001).
Dasotraline maintained significant separation from placebo on the
SKAMP-CS over time, 12 to 24 hours post-dose, supporting up to 24-hour
duration of effect.
Dasotraline demonstrated statistically significant improvement compared
to placebo on multiple secondary endpoints, including SKAMP subscales
measuring attention (least squares [LS] mean change from baseline at Day
15: -0.67 [95% CI: -1.22, -0.11] vs 0.79 [0.23, 1.35], respectively;
effect size (ES) = 0.81, p<0.0001) and deportment (least squares [LS]
mean change from baseline at Day 15: -1.44 [95% CI: -2.14, -0.75] vs
0.16 [-0.55, 0.86], respectively; effect size (ES) = 0.70, p≤0.0006).
Statistically significant improvement was also seen on the Permanent
Product Measure of Performance (PERMP) scale measuring attention and
performance based on the number of attempted and completed math problems.
Dasotraline 4 mg/day was generally well tolerated with an adverse event
(AE) profile consistent with completed studies in children and adults.
The most common treatment-emergent adverse events (TEAEs) (reported in 5
percent or more of patients and greater than placebo) included insomnia,
decreased appetite, affect lability (rapid change in emotion), headache
and irritability.
About Study SEP360-305
The SEP360-305 study was a Phase 3, two-week, randomized, double-blind,
multi-center, placebo-controlled, fixed-dose study comparing dasotraline
with placebo in 112 children six to 12 years of age with ADHD in the
U.S. Dasotraline 4 mg or placebo was administered once daily. The
primary endpoint was the change from baseline at Day 15 in ADHD symptoms
as measured by the mean Swanson, Kotkin, Agler, M-Flynn and Pelham Scale
Combined Score (SKAMP-CS) obtained from an average of seven assessments
collected across the 12-hour classroom day (12 to 24 hours post-dose)
compared to the placebo-treated group. Secondary efficacy endpoints
included SKAMP subscales measuring attention and deportment and the
Permanent Product Measure of Performance (PERMP) scale measuring
performance based on the number of attempted and completed math problems.
About Dasotraline
Dasotraline is a new chemical entity that is considered to be a dopamine
and norepinephrine reuptake inhibitor (DNRI). It has an extended
half-life (47-77 hours) that supports the potential for plasma
concentrations yielding a continuous therapeutic effect over the 24-hour
dosing interval. Dasotraline has shown a lower potential for abuse than
methylphenidate in clinical testing.2 Dasotraline was
discovered by Sunovion Pharmaceuticals Inc. and is currently in
development to evaluate its use in treating attention deficit
hyperactivity disorder (ADHD) and binge eating disorder (BED) in the
United States. It has not been approved by the U.S. Food and Drug
Administration (FDA) for the treatment of ADHD, BED or any other
disorder.
About Attention Deficit Hyperactivity Disorder (ADHD)
Attention deficit hyperactivity disorder (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).3 Approximately 11 percent of
children four to 17 years of age have been diagnosed with ADHD in the
United States.4 Up to 60 percent of children with ADHD
continue to experience symptoms into adulthood.5 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.6
In children, ADHD is associated with social rejection and reduced school
performance.7 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.8
In adults, symptoms reduce the quality of social or occupational
functioning.9 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.10
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.11,12,13
About Binge Eating Disorder (BED)
Binge eating disorder (BED) is characterized by recurrent episodes of
binge eating that occur at least once per week for three months. An
episode of binge eating is defined as eating an abnormally large amount
of food in a discrete period of time. This is typically accompanied by a
sense of lack of control. Binge eating must be characterized by marked
distress and at least three of the following: eating more rapidly than
normal; eating until feeling uncomfortably full; eating large amounts of
food when not feeling physically hungry; eating alone because of
embarrassment and feeling disgusted, guilty or depressed afterwards.14
The lifetime prevalence of BED among adult women and men in the United
States is 3.6 percent and 2.1 percent, respectively.15,16
BED typically begins in adolescence or young adulthood but can also
start later.17 BED can lead to a number of psychological and
physical problems, such as social isolation, feeling bad about oneself,
problems functioning at work, obesity and related medical conditions
(e.g., gastroesophageal reflux disease, joint problems, heart disease,
type 2 diabetes and some sleep-related breathing disorders).18
It is also associated with increased health care utilization, medical
morbidity and mortality.19
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. Sunovion’s track record of discovery,
development and commercialization of important therapies has included
Utibron™ Neohaler® (indacaterol/glycopyrrolate) inhalation
powder, Brovana® (arformoterol tartrate), Latuda®
(lurasidone HCI) and Aptiom® (eslicarbazepine acetate).
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, Sunovion
Pharmaceuticals Canada Inc., based in Mississauga, Ontario, and Sunovion
CNS Development Canada ULC, based in Toronto, Ontario, are wholly-owned
direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional
information can be found on the company’s web sites: www.sunovion.com,
www.sunovion.eu
and www.sunovion.ca.
Connect with Sunovion on Twitter,
LinkedIn,
Facebook
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 United States, China and the European Union.
Sumitomo Dainippon Pharma aims to create innovative pharmaceutical
products in the Psychiatry & Neurology area and the Oncology area, 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 about 6,500 employees worldwide. Additional
information about Sumitomo Dainippon Pharma is available through its
corporate website at www.ds-pharma.com.
LATUDA and SUNOVION are registered trademarks of Sumitomo Dainippon
Pharma Co., Ltd.
BROVANA is a registered trademark of Sunovion
Pharmaceuticals Inc.
APTIOM is used under license from BIAL.
UTIBRON
is a trademark of Novartis AG, used under license.
NEOHALER is a
registered trademark of Novartis AG, used under license.
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon
Pharma Co., Ltd.
© 2017 Sunovion Pharmaceuticals Inc.
For a copy of this release, visit Sunovion’s web site at www.sunovion.com
References
1 Data on file, Sunovion Pharmaceuticals Inc.
2
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.
3 American Psychiatric Association. Diagnostic
and Statistical Manual of Mental Disorders. Fifth Edition. Washington,
DC: American Psychiatric Association, 2013.
4 Centers
for Disease Control and Prevention. Attention-Deficit
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Available from: http://www.cdc.gov/ncbddd/adhd/data.html.
Accessed March 2017.
5 Targum SD. & Adler LA. Our
Current Understanding of Adult ADHD. Innovations in Clinical
Neuroscience. 2014; 11(11-12): 30–35.
6 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.
7 American Psychiatric Association.
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Washington, DC: American Psychiatric Association, 2013.
8
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Accessed March 2017.
9 American Psychiatric Association.
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Küpper, T, Haavik, J, Drexler, H, et al. The Negative Impact of
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12
Küpper, T, Haavik, J, Drexler, H, et al. The Negative Impact of
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Adults and Adolescents. International Archives of Occupational and
Environmental Health. 2012: 85(8), 837-47.
13 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.
14 American Psychiatric
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Fifth Edition. Washington, DC: American Psychiatric Association, 2013.
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Hudson, JI, Hiripi, E, Pope, HG, & Kessler, RC. (2007). The Prevalence
and Correlates of Eating Disorders in the National Comorbidity Survey
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Smink, FRE, van Hoeken, D, & Hoek, HW. Epidemiology of Eating Disorders:
Incidence, Prevalence and Mortality Rates. Current Psychiatry
Reports. 2012; 14(4), 406–14.
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Psychiatric Association. Diagnostic and Statistical Manual of Mental
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Association, 2013.
18 Mayo Clinic. Binge-Eating
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Accessed March 2017.
19 American Psychiatric
Association. Diagnostic and Statistical Manual of Mental Disorders.
Fifth Edition. Washington, DC: American Psychiatric Association, 2013.
Contacts
Sunovion Pharmaceuticals Inc.
Kristina Coppola, 508-787-4368
Senior
Manager, Corporate Communications
kristina.coppola@sunovion.com
