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

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Mar 17, 2020, 12:46 ET

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 shortages for components of our branded ADHD medications which are sourced from China or other countries 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.

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.

SOURCE Tris Pharma, Inc.