Shire plc (LON: SHP, Nasdaq: SHPGY) recently announced that a single once-daily morning dose of the investigational amphetamine compound SPD465 (extended release triple-bead mixed amphetamine salts) designed to reduce symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults for up to 16 hours, was found to be bioequivalent to a dose of ADDERALL XR (mixed salts of a single-entity amphetamine product) followed by a dose of mixed amphetamine salts immediate release ("MAS IR") eight hours later.
Such findings based on Phase I clinical trial data in healthy adults were recently presented at the 2006 U.S. Psychiatric & Mental Health Congress (USPMHC) annual meeting in New Orleans.
According to Lenard A. Adler, M.D., director of the Adult ADHD Program in the Departments of Psychiatry and Neurology at New York University (NYU) School of Medicine and author of "Scattered Minds: Hope and Help for Adults with ADHD":
"Adults with ADHD are particularly challenged by a normal day's activities that often extend into the evening and SPD465 offers the possibility of full-day symptom control.”
Shire’s New Drug Application (NDA) for SPD465 is under USFDA review. Once SPD465 gets USFDA approval, it would become the first and only ADHD stimulant product designed to control inattention, hyperactivity and impulsivity in adults for up to 16 hours with one daily dose.
Good news for the more than nine million American adults currently suffering symptoms of ADHD.
Find more details from the press release (a pdf file).
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