Tris Pharma Announces the Launch of DYANAVEL™ XR (amphetamine) Extended-release Oral Suspension, CII for the Treatment of Children with ADHD

MONMOUTH JUNCTION, N.J., April 19, 2016 /PRNewswire/ -- Tris Pharma, Inc. ("Tris") announces today the launch of DYANAVEL™ XR (amphetamine), CII, the first and only extended-release liquid amphetamine for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years and older. DYANAVEL XR is now available in U.S. pharmacies by prescription only.

DYANAVEL XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep DYANAVEL XR in a safe place to prevent misuse and abuse. Selling or giving away DYANAVEL XR may harm others, and is against the law.

Once-daily liquid DYANAVEL XR helps doctors customize the dose for each appropriate child with ADHD to balance symptom control and side effects. The starting dose is 2.5 or 5 mg, taken once daily in the morning with or without food. The low starting dose may be adjusted by 2.5 to 10 mg per day, every 4 to 7 days, up to a maximum dose of 20 mg per day. Doctors may be able to adjust the dose within the same prescription. Prior to prescribing a central nervous system (CNS) stimulant, including DYANAVEL XR, a healthcare provider should assess for the presence of heart disease.

"DYANAVEL XR was evaluated in a laboratory classroom setting in children with ADHD aged 6 to 12 years and was shown to improve attention and behavior and helped decrease impulsivity and hyperactivity," said Ann Childress, M.D., lead investigator and President of the Center for Psychiatry and Behavioral Medicine, Las Vegas. "DYANAVEL XR demonstrated a statistically significant difference versus placebo starting at one hour and lasting up to 13 hours after dosing, as measured by the Swanson, Kotkin, Agler, M-Flynn, and Pelham rating scale (SKAMP)."

DYANAVEL XR received approval from the U.S. Food and Drug Administration (FDA) in October 2015. Based on limited experience with DYANAVEL XR, side effects appear to be similar to other once-daily ADHD medicines with the same active ingredient. The most common side effects reported in the Phase 3 controlled study were epistaxis (nosebleed) (DYANAVEL XR 4%, placebo 0%), allergic rhinitis (4%, 0%) and upper abdominal pain (4%, 2%).

"We are proud to be the only pediatric company in the world to launch an extended-release liquid amphetamine that provides ADHD symptom control from breakfast through homework time," said Ketan Mehta, President and Chief Executive Officer of Tris Pharma. "Tris Pharma remains committed to bringing age-appropriate formulations to market to address unmet medical needs for pediatric patients."

About ADHD
According to the Centers for Disease Control and Prevention's 2011 data, 11% of children aged 4-17 years in the U.S. have received an ADHD diagnosis at some point in their life.¹ 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.²

About DYANAVEL XR

What is DYANAVEL XR?
DYANAVEL XR is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). DYANAVEL XR may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

It is not known if DYANAVEL XR is safe and effective in children under 6 years of age.

IMPORTANT SAFETY INFORMATION

DYANAVEL XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep DYANAVEL XR in a safe place to prevent misuse and abuse. Selling or giving away DYANAVEL XR may harm others, and is against the law. 

Tell your physician if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

DYANAVEL XR should not be taken if you or your child are allergic to amphetamine or any of the ingredients in DYANAVEL XR, or are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.

DYANAVEL XR can cause serious side effects. Tell the doctor:

• if you or your child have heart problems or heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in children and adolescents 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 DYANAVEL XR. 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 DYANAVEL XR.
• 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.
• if your child is having slowing of growth (height and weight); DYANAVEL XR may cause this serious side effect. Your child should have his or her height and weight checked often while taking DYANAVEL XR. The doctor may stop treatment if a problem is found during these check-ups.
• if you or your child are pregnant, breastfeeding, or plan to become pregnant or breastfeed.

Common side effects of amphetamine products include:

• dry mouth
• stomach pain
• restlessness
• increased heart rate
• decreased appetite
• nausea
• extreme mood changes
• weight loss
• trouble sleeping
• dizziness

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.

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.

For additional safety information, click here for Full Prescribing Information, including Boxed Warning about 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.

¹ Visser 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.
² American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, VA: American Psychiatric Association; 2013.

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SOURCE Tris Pharma, Inc.

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