PHILADELPHIA, PA, USA I October 9, 2014 I Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that it has received further guidance from the U.S. Food and Drug Administration (FDA) on the regulatory path for SHP 465 (triple-bead mixed amphetamine salts MAS), an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. On April 25, 2014, in written correspondence, the FDA responded to Shire’s resubmission proposal package confirming that Shire could submit SHP 465 as a Class 2 resubmission. After a series of follow-up discussions, the FDA has now clarified that additional pediatric data would be required. This information will impact Shire’s plans for a 2014 New Drug Application (NDA) resubmission for SHP 465.
SHP 465 has the potential to be an important treatment option for adults with ADHD, and Shire is engaging with the FDA to define the clinical data requirements.
ABOUT ADHD IN ADULTS
Attention-Deficit/Hyperactivity Disorder 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.
An estimated 4.4% of adults met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, (DSM-4®) criteria for ADHD in the US based on clinical interview. When extrapolated to the full US adult population aged 18 and over, approximately 10.5 million adults were estimated to have ADHD in the US.
The specific etiology of ADHD is unknown. The diagnosis is made utilizing criteria specified in the DSM-5 or International Classification of Diseases, 10th revision (ICD-10). Only a trained health care professional can evaluate and diagnose ADHD.
Although there is no cure for ADHD, there are accepted treatments that have been demonstrated to improve symptoms. Standard treatments include educational approaches, psychological therapies which may include behavioral modification, and/or medication. Ongoing assessment and treatment may be necessary.
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.
SOURCE: Shire
Post Views: 117
PHILADELPHIA, PA, USA I October 9, 2014 I Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that it has received further guidance from the U.S. Food and Drug Administration (FDA) on the regulatory path for SHP 465 (triple-bead mixed amphetamine salts MAS), an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. On April 25, 2014, in written correspondence, the FDA responded to Shire’s resubmission proposal package confirming that Shire could submit SHP 465 as a Class 2 resubmission. After a series of follow-up discussions, the FDA has now clarified that additional pediatric data would be required. This information will impact Shire’s plans for a 2014 New Drug Application (NDA) resubmission for SHP 465.
SHP 465 has the potential to be an important treatment option for adults with ADHD, and Shire is engaging with the FDA to define the clinical data requirements.
ABOUT ADHD IN ADULTS
Attention-Deficit/Hyperactivity Disorder 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.
An estimated 4.4% of adults met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, (DSM-4®) criteria for ADHD in the US based on clinical interview. When extrapolated to the full US adult population aged 18 and over, approximately 10.5 million adults were estimated to have ADHD in the US.
The specific etiology of ADHD is unknown. The diagnosis is made utilizing criteria specified in the DSM-5 or International Classification of Diseases, 10th revision (ICD-10). Only a trained health care professional can evaluate and diagnose ADHD.
Although there is no cure for ADHD, there are accepted treatments that have been demonstrated to improve symptoms. Standard treatments include educational approaches, psychological therapies which may include behavioral modification, and/or medication. Ongoing assessment and treatment may be necessary.
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.
SOURCE: Shire
Post Views: 117
