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Adzenys XR-ODT is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. Adzenys XR-ODT is not approved for use in patients less than 6 years of age.
“The presentation of this data at AACAP today demonstrates our commitment to completing post-marketing requirements for Adzenys XR-ODT, in particular addressing the limited clinical data for ADHD medications in the preschool age population, ages 4 to 5 years. The results from this study, as well as additional planned studies, will better characterize the clinical profile for Adzenys XR-ODT in this ADHD population,” stated
Today’s poster presentation will include data from a recently-completed study on the oral bioavailability and pharmacokinetic profile of Adzenys XR-ODT in preschool age children (ages 4 to 5 years) with ADHD. Dr.
Session: New Research Poster
Date & Time:
Title: A Phase 4, Open-Label, Multicenter, Single-Dose Study of the Pharmacokinetics of a Novel Extended-Release Oral Disintegrating Tablet Formulation (Adzenys XR-ODT) in Preschool-Aged Children
Important Safety Information for Adzenys XR-ODT
Adzenys XR-ODT is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Adzenys XR-ODT in a safe place to prevent misuse and abuse. Selling or giving away Adzenys XR-ODT may harm others and is against the law.
Tell your doctor if you or your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Who should not take Adzenys XR-ODT?
Do not take Adzenys XR-ODT if you or your child is:
- allergic to amphetamine or any ingredients in Adzenys XR-ODT.
- taking or has taken an anti-depression medicine called monoamine oxidase inhibitor (MAOI) within the past 14 days.
Adzenys XR-ODT is a stimulant medicine. Tell your doctor about health conditions, including if:
- you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in people with heart problems or defects, and sudden death, stroke and heart attack have happened in adults. Your doctor should check for heart problems prior to prescribing Adzenys XR-ODT and will check you or your child’s blood pressure and heart rate during treatment. Call the doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking either Adzenys XR-ODT.
- you or your child has mental problems, or a family history of suicide, bipolar illness, or depression. This is important because the following could occur: new or worse behavior and thought problems, new or worse bipolar illness, new psychotic symptoms (hearing voices, believing things that are not true, are suspicious) or new manic symptoms. Call the doctor right away if there are any new or worsening mental symptoms during treatment.
- you or your child has circulation problems in fingers and toes (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 Adzenys XR-ODT.
- you or your child is having symptoms of serotonin syndrome which may happen when Adzenys XR-ODT is taken with certain other medicines and may be life threatening. Call your doctor or go to the nearest hospital emergency room if you have any of the following symptoms: agitation, hallucinations, coma or other changes in mental status, problems controlling your movements or muscle twitching, fast heartbeat, high or low blood pressure, sweating or fever, muscle stiffness or tightness, nausea, vomiting or diarrhea.
- your child is having slowing of growth (height and weight). Your child should have his or her height and weight checked often while taking Adzenys XR-ODT. The doctor may stop treatment if a problem is found during these check-ups.
- you or your child has kidney problems. Your doctor may lower the dose.
- you or your child is, or plans to become pregnant. If you or your child becomes pregnant during treatment with Adzenys XR-ODT, talk to your doctor about registering with the National Pregnancy Registry for Psychostimulants.
- you or your child is breastfeeding, or plans to breastfeed. You or your child should not breastfeed while taking Adzenys XR-ODT.
- you or your child takes any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Adzenys XR-ODT and some medicines may interact with each other and cause serious side effects.
Do not start any new medicine while taking Adzenys XR-ODT without talking to your doctor first.
What should I avoid while taking Adzenys XR-ODT?
- drinking alcohol.
Common side effects for Adzenys XR-ODT include:
- Children 6 – 12 Years: Decreased appetite, problems sleeping, stomach pain, extreme mood change, vomiting, nervousness, nausea, and fever.
- Children 13 – 17 Years: Decreased appetite, problems sleeping, stomach pain and weight loss, and nervousness.
- Adults: Dry mouth, decreased appetite, problems sleeping, headache, weight loss, nausea, anxiety, restlessness, dizziness, fast heartbeat, diarrhea, weakness, and urinary tract infections.
These are not all the possible side effects of Adzenys XR-ODT. Call your doctor for medical advice about side effects.
What is Adzenys XR-ODT?
Adzenys XR-ODT is a central nervous system (CNS) stimulant prescription medicines used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. Adzenys XR-ODT is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep Adzenys XR-ODT in a safe place to protect it from theft. Selling or giving away your Adzenys XR-ODT may cause death or harm to others and is against the law.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-
According to the Centers for Disease Control and Prevention, ADHD is one of the most common neurodevelopmental disorders of childhood, occurring in about 5% of children.i,ii Clinical features including inattentiveness, hyperactivity and impulsiveness are seen in many settings and can cause significant impact on academic, social, and family functioning.
One in three children with ADHD in the US are diagnosed during the preschool years (<6 years of age).iii The recommended first line of treatment is behavioral therapy, with stimulant medications reserved for children in whom behavioral therapy does not provide significant improvement.iv,v Pharmacotherapy is used in almost 20% of preschoolers with ADHD, although most
Vice President Clinical Affairs
Richard I. Eisenstadt
Chief Financial Officer
Adzenys XR-ODT® is a registered trademark of
iii Visser SN et al. Diagnostic experiences of children with Attention-Deficit/Hyperactivity Disorder. Natl Health Sta Report. 2015
iv Wolraich et al. ADHD: Clinical practice guideline for the diagnosis, evaluation, and treatment of Attention-Deficit/Hyperactivity Disorder in children and adolescents. Subcommittee on Attention Deficit Hyperactivity Disorder, J Peds 2011 Nov; 128(5): 000-16
v Pliszka SR. Pharmacological treatment of Attention-Deficit/Hyperactivity Disorder: Efficacy, safety, and mechanisms of action. Neuropsychol Rev 2007 17:61-72.
vi Danielson ML, et al. Prevalence of parent-reported ADHD diagnosis and associated treatment among US children and adolescents, 2016. J Clin Child Adolesc Psychol. 2018 Mar-Apr; 47(2):199-212.