Shire plc (LON: SHP, NASDAQ: SHPGY) has recently submitted a new drug application (NDA) to the USFDA for its investigational compound guanfacine extended release (previously referred to as SPD503), which when approved will become the first once-daily selective alpha-2A-adrenoceptor agonist for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 to 17 years.
Shire’s proposed trade name for guanfacine extended release is CONNEXYN™. The said application is subject to a 10-month USFDA review period.
According to Matthew Emmens, Shire's Chief Executive Officer:
"The NDA submission of guanfacine extended release is another Shire milestone in the development of our ADHD portfolio, demonstrating further our ability to execute on our strategy for continued growth.
As the first selective alpha-2A-adrenoceptor agonist submitted to the FDA for the treatment of ADHD, CONNEXYN, if approved, would enhance our product portfolio as a new non-stimulant ADHD medication, reaffirming our commitment to the ADHD community in providing a range of effective treatment options for this disorder."
Shire plc has already initiated a Phase IIIb clinical trial to assess the safety and efficacy of guanfacine extended release in children with ADHD who also exhibit oppositional behavior, in its continued effort to develop the product.
Read the Shire press release.
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