Highland Therapeutics launches Phase II testing of nighttime ADHD drug

Highland Therapeutics, a Toronto-based company with delayed-release technology for ADHD treatment, is launching a Phase II study of its drug HLD100 designed for nighttime dosing of ADHD patients to improve their functioning when they wake.

The study is being conducted by Highland’s subsidiary, Ironshore Pharmaceuticals & Development, and uses that group’s proprietary delayed-release and extended-release technology.

Dubbed HLD100-103, the study will enroll 24 pediatric patients from the ages of 6 through 12, with the goal of demonstrating that evening dosing with HLD100 can be “well tolerated” by young patients, the company said.

Of the current options available to pediatric ADHD patients, none “address the primary shortcoming of otherwise effective stimulant medications: the lack of effective symptom control and impaired functioning during the morning routine,” said David Lickrish, Ironshore’s president and CEO, in a statement.

In a survey by Ironshore, many families reported uncontrolled ADHD symptoms and associated functional impairments in children during early morning routines. About 29% of respondents reported the level of impairment as “severe” and another 47% rated it as “moderate.”

In April, Highland reported promising results from the first of two Phase III trials for its ADHD drug Benjorna, which is a delayed-release and extended-release methylphenidate capsule.

Controlling ADHD symptoms in a delayed-release manner has become a focus in treating the disorder as companies like Pfizer ($PFE), Neos Therapeutics ($NEOS), Noven Pharmaceuticals and others tailor their delivery options with once-daily, extended-release and even patch options.

- see Highland’s release

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