Shire plc (NASDAQ: SHPGY) has submitted a new drug application (NDA) to the USFDA for SPD465, an investigational amphetamine compound for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in the adult population.
SPD465, though containing the same active ingredient as ADDERALL XR® (mixed salts of a single-entity amphetamine product) is designed to provide ADHD symptom control for up to 16 hours.
The NDA is subject to a 12-month USFDA review period but when approved, this novel product will be the first and only ADHD stimulant product that controls inattention, hyperactivity and impulsivity for up to 16 hours.
ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than typically observed in individuals at a comparable age and maturity level.
Scientists now agree that up to 65 percent of adolescents with ADHD will continue to have the ADHD diagnosis as adults.
For further information on ADHD please visit the following websites: ADDERALL XR®, ADHD Support, CHAD, NMHA.
Read more about the SPD465 NDA at the Shire plc press release.
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