Shire Agrees to FDA Request to Conduct Clinical Trials Investigating the Potential Use of Vyvanse(R) (lisdexamfetamine dimesylate) in Preschool-Age Children with ADHD
LEXINGTON, Massachusetts, Jun 12, 2014 (PR Newswire Europe via COMTEX) -- LEXINGTON, Massachusetts, June 12, 2014 /PRNewswire/ --
Shire plc today announced that it has agreed to a Written Request by the Food and Drug Administration (FDA) to conduct pediatric clinical studies to investigate the potential use of Vyvanse(R) (lisdexamfetamine dimesylate) for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in preschool-age children, ages 4 to 5.
"Shire is committed to continuing to add to the scientific body of knowledge about ADHD treatment options for patients," said Philip Vickers, Ph.D., Head of Research and Development at Shire. "Additional efficacy and safety data will help clinicians and parents make informed treatment decisions for preschool-age children with ADHD."
Currently there are few adequate and well-controlled studies of pharmacotherapy in preschool-age children with ADHD. Shire is in the process of developing design protocols for three clinical trials with Vyvanse that will make up the clinical trial program in preschool children: a pharmacokinetic study to help determine appropriate dosing and evaluate safety and tolerability; an efficacy and safety study; and an open-label study to evaluate long-term safety. A Data Monitoring Committee will also be established to monitor patient safety throughout the duration of the clinical program. Shire anticipates beginning the first trial in the preschool pediatric clinical trial program in the first half of 2015.
Upon FDA confirmation of a timely submission and review of data that adheres to the requirements of the Written Request, Shire will be entitled to the benefits of the Best Pharmaceuticals for Children Act, including a six-month extension to the exclusivity afforded by Shire's patents for Vyvanse, which expire in 2023.
Vyvanse is a prescription medicine currently only approved for the treatment of ADHD in the United States, Canada, Australia, Mexico and several European countries (trade name:Elvanse(R)/Tyvense(R)) and Brazil (trade name: Venvanse(TM)). Vyvanse should only be used in accordance with locally approved prescribing information. In the U.S., Vyvanse is approved for the treatment of ADHD in patients age 6 and above.
CNS stimulants (amphetamines and methylphenidate-containing products) 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.
ABOUT ADHD IN PRESCHOOL CHILDREN
ADHD is a neurobehavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development and is inconsistent with developmental level. The estimated prevalence of ADHD in the preschool population is three to five percent. Data suggest that only a small proportion of preschool-age children with ADHD respond adequately to behavioral therapy.
ABOUT Vyvanse(R) (lisdexamfetamine dimesylate)
Information about Vyvanse
Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Vyvanse may harm others and is illegal.
Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients 6 years and above. Vyvanse capsules are currently available in six once-daily dosage strengths of 20mg, 30mg, 40mg, 50mg, 60mg, and 70mg.
ADDITIONAL IMPORTANT SAFETY INFORMATION
- Do not take Vyvanse if you or your child:
- is taking or has taken within the past 14 days an anti-depression medicine
called a monoamine oxidase inhibitor or MAOI
- is sensitive to, allergic to, or had a reaction to other stimulant
- Some people have had the following problems when taking stimulant
medicines, such as Vyvanse:
1.Heart-related problems including:
- sudden death in people who have heart problems or heart defects
- sudden death, stroke and heart attack in adults
- increased blood pressure and heart rate
Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. The doctor should check your or your child's blood pressure and heart rate regularly during treatment.
Call your 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 Vyvanse.