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SOURCE Shire plc
LEXINGTON, Massachusetts, June 12, 2014 /PRNewswire/ --
Shire plc (LSE: SHP, NASDAQ: SHPG) 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® (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®/Tyvense®) and Brazil (trade name: Venvanse™). 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® (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
1. Heart-related problems including:
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.
2. Mental (psychiatric) problems including:
In Children and Teenagers
Tell your doctor about any drug abuse, alcohol abuse or mental problems that you or your child has had, or about a family history of suicide, bipolar illness, or depression.
Call your doctor right away if you or your child has any new or worsening mental symptoms or problems while taking Vyvanse.
3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud's phenomenon]:
Call your doctor right away if you have or your child has any of these signs or symptoms or develops unexplained wounds on fingers or toes while taking Vyvanse.
For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor.
NOTES TO EDITORS
Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.
We provide treatments in Neuroscience, Rare Diseases, Gastrointestinal, and Internal Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmology.
FORWARD-LOOKING STATEMENTS - "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included in this announcement that are not historical facts are forward-looking statements. Forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, that:
and other risks and uncertainties detailed from time to time in Shire's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K.
For further information please contact:
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