Mar 17, 2020   SOURCE: PR NewsWire

Quillivant XR®, QuilliChew ER® and Dyanavel® XR are 100% Made in the U.S.A. and Remain Consistently Supplied During COVID-19 Pandemic

MONMOUTH JUNCTION, N.J., March 17, 2020 /PRNewswire/ -- Tris Pharma, Inc. ("Tris"), a specialty pharmaceutical company with a robust portfolio of approved products for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and related disorders, amidst the uncertainty created by the COVID-19 pandemic, reiterated its commitment to the ADHD community by assuring ADHD patients, caregivers and health care professionals of the continuity of supply of its family of ADHD products. Specifically, Tris reminded the ADHD community that:

    --  Quillivant XR (methylphenidate HCl), QuilliChew ER (methylphenidate HCl)
        and Dyanavel XR (amphetamine) are manufactured and packaged in the
        United States and;
    --  No components of our branded ADHD medications are sourced from China or
        other countries heavily affected by the COVID-19

Additionally, Tris is proactively addressing the maintenance and potential increase of product availability by:

    --  Increasing the production of our branded products and maintaining larger
        safety stocks in our inventory
    --  Requesting the wholesalers to increase their stocking of our medications
        at regional distribution centers

"We are honored to be entrusted with providing the highest quality prescription ADHD medications to our many patients affected by ADHD," said Ketan Mehta, Chief Executive Officer of Tris Pharma. "We will continue to monitor the ever-changing pandemic environment and will adjust as necessary to meet the needs of our patients and their health care professionals."

Quillivant XR, QuilliChew ER, and Dyanavel XR are approved for treatment of ADHD in people 6 years and older. See products' Approved Use and Important Safety Information, including Boxed Warning about Abuse and Dependence, below.

About Tris Pharma

Tris Pharma is a specialty pharmaceutical company focused on the development and commercialization of innovative medicines that address unmet patient needs. Tris has pioneered the delivery of long-acting liquid, chewable, orally-disintegrating, and film strip dosage forms that can accommodate the unique needs of a wide variety of patients. Tris' fully integrated research, manufacturing, medical and commercial facilities are located in Central New Jersey. For more information, please visit www.trispharma.com

APPROVED USE

Dyanavel XR, Quillivant XR, and QuilliChew ER are central nervous system (CNS) stimulant prescription medicines used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years and older. These medicines may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if Dyanavel XR, Quillivant XR, and QuilliChew ER are safe and effective in children under 6 years of age.

IMPORTANT SAFETY INFORMATION

Dyanavel XR, Quillivant XR, and QuilliChew ER are federally controlled substances (CII) because they can be abused or lead to dependence. Keep these medicines in a safe place to prevent misuse and abuse. Selling or giving away these medicines may harm others and is against the law. Tell your doctor if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Dyanavel XR, or Quillivant XR and QuilliChew ER, should not be taken if you or your child are allergic to amphetamine or methylphenidate hydrochloride, respectively, or any of the ingredients in these medicines, or are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.

Dyanavel XR, Quillivant XR, and QuilliChew ER can cause serious side effects. Tell the doctor:

    --  if you or your child have heart problems, heart defects, high blood
        pressure, or a family history of these problems. This is important
        because sudden death has occurred in children 6 to 17 years old with
        heart problems or defects, and sudden death, stroke, and heart attack
        have happened in adults. Your doctor should check you or your child
        carefully for heart problems before starting any of these medicines.
        Since increases in blood pressure and heart rate may occur, the doctor
        should regularly check these during treatment. Call the doctor right
        away if you or your child have any signs of heart problems such as chest
        pain, shortness of breath, or fainting while taking any of these
        medicines.
    --  if you or your child have mental problems, or a family history of
        suicide, bipolar illness, or depression. This is important because new
        or worsening behavior and thought problems or bipolar illness may occur.
        New symptoms such as seeing or hearing things that are not real,
        believing things that are not true, being suspicious, or having new
        manic symptoms may occur. Call the doctor right away if there are any
        new or worsening mental symptoms during treatment.
    --  if you or your child have circulation problems in fingers and toes
        (called peripheral vasculopathy, including Raynaud's phenomenon).
        Fingers or toes may feel numb, cool, painful, sensitive to temperature,
        and/or change color from pale, to blue, to red. Call the doctor right
        away if any signs of unexplained wounds appear on fingers or toes while
        taking Dyanavel XR, Quillivant XR, or QuilliChew ER.
    --  if your child is having slowing of growth (height and weight); Your
        child should have his or her height and weight checked often while
        taking Dyanavel XR, Quillivant XR, or QuilliChew ER.
    --  if you or your child develop painful and prolonged erections (priapism),
        seek medical help right away. Priapism has occurred with methylphenidate
        (Quillivant XR and QuilliChew ER). Because priapism can cause
        long-lasting damage, it should be checked by a doctor right away.
    --  if you or your child have symptoms of serotonin syndrome - agitation,
        hallucinations, coma, or other changes in mental status; fast heartbeat;
        sweating or fever; nausea, vomiting, diarrhea; high or low blood
        pressure; problems controlling movements or muscle twitching; muscle
        stiffness or tightness. Serotonin syndrome may occur when Dyanavel XR is
        taken with certain other medicines and may be life-threatening. Stop
        Dyanavel XR and call your doctor or go to the nearest hospital emergency
        room.
    --  if you or your child have phenylketonuria (PKU). QuilliChew ER contains
        phenylalanine as part of the artificial sweetener, aspartame. The
        artificial sweetener may be harmful to people with PKU or who are
        allergic to phenylalanine.
    --  if you or your child are pregnant or plan to become pregnant. It is not
        known if Dyanavel XR, Quillivant XR, or QuilliChew ER will harm your
        unborn baby. Tell your doctor if you or your child become pregnant
        during treatment with any of these medicines.
    --  if you or your child is breastfeeding or plan to breastfeed.  Dyanavel
        XR, Quillivant XR, and QuilliChew ER pass into breast milk. You or your
        child should not breastfeed while you are taking any of these medicines.

Common side effects of amphetamine products include:



     dry mouth          
     stomach pain     
     extreme mood changes



     decreased appetite 
     nausea           
     dizziness



     weight loss        
     trouble sleeping 
     increased heart rate


                         
     restlessness

Common side effects of methylphenidate products include:

    --  decreased appetite
    --  trouble sleeping
    --  nausea
    --  vomiting


    --  indigestion
    --  stomach pain
    --  weight loss
    --  anxiety
    --  dizziness


    --  irritability
    --  mood swings
    --  fast heart beat
    --  increased blood pressure

Talk to your doctor if you or your child have any side effects that bother you or do not go away.

Avoid drinking alcohol while taking Dyanavel XR, Quillivant XR, or QuilliChew ER<tt>. </tt>

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

See Medication Guide and Full Prescribing Information for Dyanavel XR, Quillivant XR, and QuilliChew ER, including Boxed Warning about Abuse and Dependence.

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SOURCE Tris Pharma, Inc.