Canada-based Highland Therapeutics has reported positive results from a Phase I study of a novel formulation of methylphenidate, HLD-200, to treat attention-deficit/hyperactivity disorder (ADHD).
Conducted in collaboration with the Harvard Clinical Research Institute (HCRI) and Massachusetts General Hospital (MGH), the study of HLD-200 was conducted on humans for the first time to examine its pharmacokinetic profile.
The study noted a longer absorption window for HLD-200, when compared with other methylphenidate products available in the market.
In the single-centre, single-dose, open-label trial, 12 patients were enrolled and administered with two methylphenidate HCl modified release and an immediate release methylphenidate HCl marketed formulations subsequent to a washout period between treatments.
The study highlights the class-leading low level of variability with respect to a critical parameter, the time to maximum concentration (Tmax), and a similar low coefficient of variation (CV%) to that of the HLD-100 Phase-1 study.
Senior study adviser and medical monitor, MGH paediatric psychopharmacology and adult ADHD clinical and research programmes chief Dr Joseph Biederman said, "The data suggest that Highland has developed a potential new treatment option for ADHD that could consistently deliver the medication so that the symptoms of ADHD can be controlled immediately upon wakening while also providing once-daily coverage."
Highland chief executive officer David Lickrish said the data for both amphetamine and methylphenidate programmes suggest that the drug-delivery technology is a platform technology, applicable to other active ingredients in a range of therapeutic categories.
"The third-party market research we have conducted indicates substantial pent-up demand for Highland's products, which could become first-line therapy in both the adult and pediatric/adolescent patient populations," Lickrish added.