Morning

Change the Delivery, Change the Day.®

Leveraging proprietary technologies to address significant unmet medical needs.

DELEXIS® - Proprietary Drug Delivery Platform ("DDP")

Ironshore Pharmaceuticals & Development, has developed a novel oral, once-daily, drug delivery technology. DELEXIS® allows drugs to be dosed at night, targeting onset of action prior to awakening.

The DELEXIS® Method of Action

Learn more about the DELEXIS® DDP's micro-bead technology, and how it works to delay the absorption of drug doses.

DELEXIS® in the GI Tract

Watch the DELEXIS® micro-beads in action and see the controlled release of drugs as the beads move through a patient from ingestion to absorption.

The DELEXIS® Platform in Application

Learn how the DELEXIS® DDP can be used to optimize the delivery of existing medicines.

ADHD and the Early Morning Routine


ADHD Morning Website

ADHDmorning.com is a dedicated website providing information and tools to help understand the impact and symptoms of ADHD as they relate to the early morning routine.

Medical professionals:

Visit ADHDmorning.com

Parents and Caregivers:

Download tips and tools guides by age group:

Ages 6–8Ages 9–12Ages 13–17

The ADHD Market

ADHD Family Prevalence

ADHD is among the most common childhood psychiatric conditions with an estimated prevalence range of 5.9% to 7.1% in children and adolescents

ADHD US Split

In the U.S., the world’s largest ADHD market, prescription volume is split approximately equally among adults and children/adolescent patients.

Central Nervous System Stimulants

Stimulant Chart 1

Stimulant medications used at appropriate dosing levels appear more robust compared to non-stimulant treatment options.

Stimulant Chart 2

In 2014, 57.6 million stimulant medication prescriptions were written based on primary diagnosis codes of ADHD, approx. 91.5% of ADHD market volume in the U.S.

Early Morning Functioning

Time lapse before stimulant effectiveness

Current oral treatment options are dosed in the early morning, leaving the patient essentially unmedicated until drug plasma concentrations reach therapeutic levels.

Children awoken early

To address this issue, some parents wake their children up before their normal awakening time to administer their child’s medication and then let them go back to sleep.

The Early Morning Routine

Learn about the challenges faced by families dealing with the symptoms of ADHD, and how important the early morning routine is for their quality of life.



The Before School Functioning Questionnaire (BSFQ)


The BSFQ measures both behaviors and functions associated with the post-waking, early morning period in children and adolescents with ADHD

Download the BSFQ

Our ADHD Pipeline – Drug Candidates in Clinical Investigation

Ironshore Pharmaceuticals & Development, Inc. has the following drug candidates under investigation:


HLD200

Indication: ADHD

Compound: Methylphenidate

HLD200 at Phase III

HLD200 is a novel formulation of methylphenidate based on the DELEXIS® technology. HLD200 is designed to be taken once-daily in the evening with the objective of controlling symptoms of ADHD immediately upon awakening and throughout the day. Two successful pivotal Phase III studies were completed in 2016. The FDA accepted for review the New Drug Application for HLD200 in 2016 and the expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is July 30, 2017.


HLD100

Indication: ADHD

Compound: Amphetamine

HLD100 at Phase II

HLD100 is a novel formulation of amphetamine based on the DELEXIS® technology. HLD100 is designed to be taken once-daily in the evening with the objective of controlling symptoms of ADHD immediately upon awakening and throughout the day. A Phase III Pivotal trial is planned for 2017.