Shire Targets SHP465 ADHD Resubmission 10 Years After Initial Filing
This article was originally published in The Pink Sheet Daily
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.
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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.
Shire is keeping two pending NDAs for new attention deficit hyperactivity disorder treatments in a sort of limbo while it waits to see if the high expectations for the launch of its d-amphetamine prodrug Vyvanse are fulfilled
With an adult filing for Adderall replacement Vyvanse set for mid year, the company is weighing its options, Shire told “The Pink Sheet” DAILY.