MONMOUTH JUNCTION, N.J.–(BUSINESS WIRE)–#ADHD—Tris
Pharma, Inc. (“Tris”) announced that results from a laboratory
classroom study of DYANAVEL XR (amphetamine) extended-release oral
suspension, CII, the first and only extended-release liquid amphetamine
for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in
children aged six years and older, were presented at the 2017
American Professional Society of ADHD and Related Disorders (APSARD)
Annual Meeting held in Washington, D.C. The study concluded that
DYANAVEL XR was effective in reducing symptoms of ADHD
from one to 13 hours after dosing in children aged six to 12 years, with
a safety profile similar to other extended-release amphetamines.
The findings were presented in a poster, “The Efficacy and Safety of
Amphetamine Extended-Release Oral Suspension (AMPH EROS) in Children
With ADHD,” presented by Ann C. Childress, M.D., President of the
Center for Psychiatry and Behavioral Medicine, Las Vegas, NV. The
presentation was selected by the APSARD organizers to be featured in the
conference Poster Tour.
“It’s important to establish and maintain effective control of symptoms
in children with ADHD,” said Dr. Childress. “This study demonstrates the
effectiveness of DYANAVEL XR in both onset of action at 1 hour
post-dose, and a duration of efficacy extending to 13 hours post-dose.”
“Tris is committed to providing pediatric-friendly treatment options for
children,” said Sally A. Berry, M.D., Ph.D., Chief Medical Officer for
Tris Pharma. “This work is evidence of our efforts to produce complete
profiles of our pediatric products through robust research to inform
clinical decision making. Doctors and their patients deserve no less.”
About the Study
The trial was designed as a dose-optimized,
randomized, double-blind, placebo-controlled laboratory classroom study
in patients aged six to 12 years with ADHD. The study enrolled 108
patients. Efficacy was assessed by school teachers and raters using the
Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale, which
is a standard tool that assesses behavior and attention in laboratory
Key findings include:
DYANAVEL XR met its primary endpoint of change from pre-dose in the
SKAMP-Combined score at 4 hours post-dosing (P<0.0001).
DYANAVEL XR also met key secondary endpoints by demonstrating an onset
of clinical effect at one hour that persisted through 13 hours
post-dosing compared to placebo.
DYANAVEL XR was well tolerated in this study, with a safety profile
similar to other extended release amphetamines.
DYANAVEL XR received approval from the U.S. Food and Drug Administration
(FDA) in October 2015. Based on clinical trial experience with DYANAVEL
XR, side effects appear to be similar to other once-daily ADHD medicines
with the same active ingredient. The most common (≥2% in the DYANAVEL XR
group and greater than placebo) adverse reactions reported in the Phase
3 controlled study conducted in 108 patients with ADHD (aged 6–12 years)
were: epistaxis (DYANAVEL XR 4%, placebo 0%), allergic rhinitis (4%, 0%)
and upper abdominal pain (4%, 2%).
As is the case with other stimulant medications because of its potential
for abuse, DYANAVEL XR is classified as a controlled substance (CII).
ADHD is one of the most common neurobehavioral
disorders characterized by an ongoing pattern of inattention and/or
hyperactivity/impulsivity. These behaviors can interfere with
functioning or development.1 According to the Centers for
Disease Control and Prevention’s 2011 data, 11 percent of children aged
four to 17 years in the U.S. have received an ADHD diagnosis at some
point in their life.2
IMPORTANT SAFETY INFORMATION AND INDICATION
DYANAVEL® XR (amphetamine)
extended-release oral suspension is a central nervous system (CNS)
stimulant indicated for the treatment of Attention Deficit Hyperactivity
IMPORTANT SAFETY INFORMATION
WARNING: ABUSE AND DEPENDENCE
CNS stimulants, including DYANAVEL XR, other
DYANAVEL XR is contraindicated
In patients known to be hypersensitive to amphetamine, or other
components of DYANAVEL XR. Hypersensitivity reactions, such as
angioedema and anaphylactic reactions, have been reported
During treatment with monoamine oxidase inhibitors (MAOIs) and
within 14 days following discontinuation of treatment with an MAOI
because of the risk of hypertensive crisis
- In patients known to be hypersensitive to amphetamine, or other
Prior to and during treatment, assess for the presence of cardiac
disease. Sudden death, stroke and myocardial infarction have been
reported in adults with CNS stimulant treatment at recommended doses.
Sudden death has been reported in children and adolescents with
structural cardiac abnormalities and other serious heart problems
taking CNS stimulants at recommended doses for ADHD. Avoid use in
patients with known structural cardiac abnormalities, cardiomyopathy,
serious heart arrhythmia, coronary artery disease, and other serious
heart problems. Further evaluate patients who develop exertional chest
pain, unexplained syncope, or arrhythmias during DYANAVEL XR treatment.
CNS stimulants can cause increases in blood pressure (mean increase
about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor
all patients for tachycardia and hypertension.
CNS stimulants may cause psychotic or manic symptoms in patients with
no prior history, or exacerbation of symptoms in patients with
pre-existing psychiatric illness. Prior to treatment, assess for the
presence of bipolar disorder.
CNS stimulants have been associated with weight loss and slowing of
growth rate in pediatric patients with ADHD. Monitor weight and height
in children during treatment with DYANAVEL XR. Treatment may need to
be interrupted in children not growing as expected.
CNS stimulants, including DYANAVEL XR, are associated with peripheral
vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are
usually intermittent and mild; very rare sequelae include digital
ulceration and/or soft tissue breakdown. Careful observation for
digital changes is necessary during treatment with ADHD stimulants.
Serotonin syndrome risk is increased when amphetamines are
co-administered with serotonergic agents (e.g., SSRIs, SNRIs,
triptans), MAOIs, and during over-dosage situations. If it occurs,
discontinue all serotonergic agents and initiate supportive treatment.
Most common adverse reactions observed with amphetamine products: dry
mouth, anorexia, weight loss, abdominal pain, nausea, insomnia,
restlessness, emotional lability, dizziness, and tachycardia. There is
limited experience with DYANAVEL XR in controlled trials. Based on
this limited experience, the adverse reaction profile of DYANAVEL XR
appears similar to other amphetamine extended-release products. The
most common (≥2% in the DYANAVEL XR group and greater than placebo)
adverse reactions reported in the Phase 3 controlled study conducted
in 108 patients with ADHD (aged 6–12 years) were: epistaxis (DYANAVEL
XR 4%, placebo 0%), allergic rhinitis (4%, 0%) and upper abdominal
pain (4%, 2%).
- DYANAVEL XR use during pregnancy may cause fetal harm.
- Breastfeeding is not recommended during treatment with DYANAVEL XR.
About Tris Pharma
Tris Pharma, Inc. is a specialty
pharmaceutical company focused on the research and development of
innovative technology-driven products. As an emerging leader in the
field of pediatric medicine, Tris Pharma will focus its brand business
on neurobehavioral disorders in pediatric patients. Tris has pioneered
the delivery of extended-release formulations in the liquid, chewable,
orally disintegrating tablet (ODT) and strip dosage forms. The Tris R&D
and manufacturing facilities are located in Monmouth Junction, N.J.,
USA. For more information, please visit www.trispharma.com
DYANAVEL is a registered trademark of Tris Pharma, Inc. © 2017 Tris
Pharma, Inc. All rights reserved.
1American Psychiatric Association. Diagnostic and
Statistical Manual of Mental Disorders. 5th ed. Arlington, VA:
American Psychiatric Association; 2013.
Danielson ML, Bitsko RH, et al. Trends in the parent-report of health
care provider-diagnosed and medicated attention-deficit/hyperactivity
disorder: United States, 2003-2011. J Amer Acad Child Adolesc