Shire Finally Gets Resuscitated Adult ADHD Drug Back On Track With FDA
This article was originally published in The Pink Sheet Daily
The 16-hour ADHD candidate SHP465 (SPD465) is being aimed at adults, but FDA wants a study in children, which will kick off in August and may allow a launch by the end of 2017, Shire says.
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Flemming Ornskov says FDA approval of long-lasting ADHD therapy Mydayis is part of Shire's plan to dramatically increase neuroscience revenues – but it won't launch the drug outside the US for some time.
Shire says it is on track to refile its long-shelved ADHD candidate SHP465 later this year after a Phase III trial in children and adolescents turned out positively.
With an adult filing for Adderall replacement Vyvanse set for mid year, the company is weighing its options, Shire told “The Pink Sheet” DAILY.