Leveraging proprietary technologies to address significant unmet medical needs.
Highland’s wholly owned subsidiary, 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.
Learn more about the DELEXIS® Drug Delivery Platform's micro-bead technology, and how it works to delay the absorption of drug doses.
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.
Learn how Highland and Ironshore Pharmaceuticals could use the DELEXIS® Drug-Delivery Platform to optimize dosing of existing drugs.
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 BSFQ measures both behaviors and functions associated with the post-waking, early morning period in children and adolescents with ADHDDownload the BSFQ
ADHD is among the most common childhood psychiatric conditions with an estimated prevalence range of 5.9% to 7.1% in children and adolescents
In the U.S., the world’s largest ADHD market, prescription volume is split approximately equally among adults and children/adolescent patients.
Stimulant medications used at appropriate dosing levels appear more robust compared to non-stimulant treatment options.
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.
Current oral treatment options are dosed in the early morning, leaving the patient essentially unmedicated until drug plasma concentrations reach therapeutic levels.
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.
HLD-200 is a novel formulation of methylphenidate based on the DELEXIS® technology. HLD-200 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 NDA for HLD200 in in 2016 and the expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is July 30, 2017.
Binge Eating Disorder (BED)
HLD-900 is a novel formulation of amphetamine based on the DELEXIS® technology. HLD-900 is designed to be taken once-daily in the evening with the objective of controlling binge-eating episodes immediately upon awakening and throughout the day. Further clinical studies are planned.
HLD-100 is a novel formulation of amphetamine based on the DELEXIS® technology. HLD-100 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.
Inflammatory Bowel Disease
Note: These drug candidates are in clinical development and have not yet been reviewed and approved by the U.S. Food and Drug Administration.