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.