Nov 12, 2018   SOURCE: PR NewsWire

Tris Pharma Presents Clinical Data for DYANAVEL® XR (amphetamine) at the 2018 Neuroscience Education Institute (NEI) Congress

MONMOUTH JUNCTION, N.J., Nov. 12, 2018 /PRNewswire/ -- Tris Pharma, Inc. (Tris), a biopharmaceutical company focused on developing innovative products that deliver meaningful patient benefits, today announced that it presented four scientific posters on DYANAVEL XR at the 2018 NEI Congress in Orlando, FL, November 7 - 11, 2018.

DYANAVEL XR is approved to treat children six years and older with Attention Deficit/Hyperactivity Disorder (ADHD). DYANAVEL XR, a central nervous system (CNS) stimulant, has a Boxed Warning about abuse and dependence. The risk of abuse should be assessed prior to prescribing DYANAVEL XR, and patients on therapy should be monitored for signs of abuse and dependence. DYANAVEL XR is contraindicated in patients with known hypersensitivity to amphetamines or other ingredients in DYANAVEL XR and in patients who are taking, or have taken within the last 14 days, a monoamine oxidase inhibitor (MAOI). Please see additional Important Safety Information below.

"Tris is committed to providing differentiated pediatric-friendly treatment options for children with ADHD," said Ketan Mehta, President and Chief Executive Officer of Tris. "DYANAVEL XR was developed utilizing our proprietary LiquiXR(®) technology delivery platform. Data from studies presented at the NEI Congress provide further insight into the role DYANAVEL XR could play in the clinical management of patients with ADHD."

The following scientific posters were presented at the NEI Congress:

Poster 32
Title: Early-Onset Efficacy and Safety Pilot Study of Amphetamine Extended-Release Oral Suspension (AMPH EROS) in the Treatment of Children with Attention-Deficit/Hyperactivity Disorder

Author Conclusion: AMPH EROS was effective in reducing ADHD symptoms at 30 minutes postdose. AEs were mild or moderate and consistent with those of other extended-release amphetamines.

Poster 88
Title: The Efficacy and Safety of Amphetamine Extended-Release Oral Suspension (AMPH EROS) in Children with Attention-Deficit/Hyperactivity Disorder

Author Conclusion: AMPH EROS was effective in reducing symptoms or ADHD from 1 to 13 hours after dosing. Adverse events reported were consistent with those of other amphetamine products.

Poster 87
Title: Open-Label Dose Optimization Study of an Amphetamine Extended-Release Oral Suspension in Children with Attention-Deficit/Hyperactivity Disorder

Author Conclusion: AMPH EROS was effective in reducing symptoms of ADHD in the OL dose optimization phase of a pivotal phase 3 analog laboratory classroom study. The AE profile of AMPH EROS was consistent with that of other amphetamine products.

Poster 89
Title: A Modified-Release Drug Delivery Technology Containing Amphetamine-Ion Exchange Complexes

Author Conclusion: The release characteristics of the LiquiXR(®) drug delivery technology are programmable and allow for a customized, sustained release of active drug product, and confer a specific product profile for AMPH EROS.

"The data presented at the 2018 NEI Congress underscore Tris' commitment to furthering research in and advancing the treatment of ADHD," stated Barry K. Herman, M.D., M.M.M., Senior Vice President and Chief Medical Officer of Tris.

About ADHD

ADHD is one of the most common neurodevelopmental disorders characterized by an ongoing pattern of inattention and/or hyperactivity and impulsivity. These behaviors can interfere with functioning or development. 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.

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



            WARNING: ABUSE AND DEPENDENCE



             CNS stimulants, including DYANAVEL XR,
              other amphetamine-containing products,
              and methylphenidate, have a high
              potential for abuse and dependence.
              Assess the risk of abuse prior to
              prescribing and monitor for signs of
              abuse and dependence while on therapy.



    ---

    --  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
    --  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.

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

About Tris Pharma

Tris Pharma is a fully integrated pharmaceutical company focused on the development of innovative medicines that address unmet patient needs. Tris has pioneered the delivery of sustained release in the liquid, chewable, orally disintegrating tablet, and strip dosage forms that benefit a wide variety of patients and their unique needs. Tris' research, manufacturing and commercial facilities are located in Central New Jersey.

For more information, please visit www.trispharma.com

DYANAVEL is a registered trademark of Tris Pharma, Inc.
© 2018 Tris Pharma, Inc. All rights reserved.

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SOURCE Tris Pharma, Inc.