FDA okays NDA resubmission of Ironshore ADHD drug HLD200

Ironshore ADHD drug HLD200 : The US Food and Drug Administration (FDA) has accepted Ironshore Pharmaceuticals & Development’s resubmission of the New Drug Application (NDA) for HLD200 for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The company, which is a subsidiary of Highland Therapeutics, said that the FDA has set a Prescription Drug User Fee Act (PDUFA) date of 8 August, 2018 for the ADHD drug approval.

A delayed-release and extended-release formulation of methylphenidate, HLD200 was designed to be dosed at nighttime to target an onset of the drug effect in the morning.

The Ironshore ADHD drug HLD200 has been developed for more than 10 years now and its new NDA is packed with findings from nine clinical trials, which comprise two pivotal phase 3 trials. Across both the late-stage trials, HLD200 succeeded in bringing statistically significant improvements in ADHD symptoms on each of the endpoints assessed.

The Ironshore ADHD drug HLD200 is the first product that uses the company’s DELEXIS technology platform. The DELEXIS drug technology enables drugs to be dosed at night to target onset of their action before waking up in the morning.