NDA for ADHD Med That Is Dosed at Night Resubmitted to FDA


The FDA has set a new PDUFA date of August 8, 2018

The FDA has set a new PDUFA date of August 8, 2018

The Food and Drug Administration (FDA) has accepted a resubmitted New Drug Application (NDA) for the investigational treatment HLD200 (Ironshore Pharmaceuticals) for attention deficit hyperactivity disorder (ADHD).

HLD200, a delayed-release and extended-release formulation of methylphenidate, was developed using the Company’s proprietary drug delivery platform, Delexis. This allows the medication¬†to be dosed in the evening so that it can target the early morning symptoms of ADHD.¬†

The new NDA includes data from 9 trials, including two Phase 3 studies in which HLD200 statistically significantly improved ADHD symptoms versus placebo in each of the endpoints evaluated.

The FDA has set a new Prescription Drug User Fee Act (PDUFA) date of August 8, 2018.



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