Tris Pharma’s Results from a Laboratory Classroom Study of DYANAVEL® XR in Children with ADHD Featured at APSARD

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
classroom studies.

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).

About ADHD
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

INDICATION
DYANAVEL^® XR (amphetamine)
extended-release oral suspension is a central nervous system (CNS)
stimulant indicated for the treatment of Attention Deficit Hyperactivity
Disorder (ADHD).

IMPORTANT SAFETY INFORMATION

• 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

  Please click here for Full
  Prescribing Information, including Boxed WARNING regarding
  potential for Abuse and Dependence, and Medication
  Guide.

  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.
  ²Visser SN,
  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
  Psychiatry. 2014;53(1):34-46.

  Contacts

  Tris Pharma Contact:
  Sharon Clarke
  Chief Commercial Officer
  sclarke@trispharma.com
  or
  Media
  Contact:
  LaVoieHealthScience
  Vivian Ni, 617-374-8800 ext. 109
  vni@lavoiehealthscience.com