Ironshore Pharmaceuticals & Development, a subsidiary of Highland Therapeutics, has reached a significant milestone with the U.S. Food and Drug Administration’s (FDA) acceptance of their resubmitted New Drug Application (NDA) for HLD200, a novel treatment for Attention Deficit Hyperactivity Disorder (ADHD). The FDA has scheduled the Prescription Drug User Fee Act (PDUFA) decision for August 8, 2018, marking a pivotal moment in the approval process for this innovative medication.

HLD200 is a delayed-release and extended-release formulation of methylphenidate, a common therapeutic agent for ADHD. What sets HLD200 apart is its unique dosing schedule—designed to be taken at night to target the onset of drug effects the following morning. This innovative approach aims to provide symptom control from the moment patients wake up, addressing a critical need in ADHD management.

The development of HLD200 leverages Ironshore’s DELEXIS technology platform, which allows for nighttime dosing with effects timed to commence in the morning hours. This technology represents a breakthrough in psychopharmacology, potentially transforming the daily lives of those affected by ADHD.

The new NDA submission for HLD200 is supported by robust clinical data, including results from nine clinical trials. Among these are two pivotal Phase 3 trials that have demonstrated statistically significant improvements in ADHD symptoms across all assessed endpoints. This extensive research underscores the drug’s effectiveness and its potential to improve patient outcomes significantly.

The advancement of HLD200 has garnered attention from both medical professionals and industry analysts. The potential approval of this drug could set a new standard in ADHD treatment, particularly in how medication timing can align more closely with patient lifestyles and symptomatology.

Experts in ADHD treatment have long noted the need for innovations that accommodate the daily rhythms of patients, especially for children and adolescents who must manage symptoms throughout the school day. Ironshore’s approach could provide a much-needed option for those seeking a different treatment schedule that fits into a nighttime routine.

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