Highland Therapeutics, a Toronto-based company with delayed-release technology for ADHD treatment, said data from the first of two Phase III trials for its drug used to treat the disorder showed a significant improvement for patients receiving the compound.
Benjorna, formerly known as HLD-200, is a delayed-release and extended-release methylphenidate capsule.
In the clinical study, which included 153 pediatric participants, those who were selected to receive Benjorna showed a "statistically significant improvement" versus patients who got the placebo, the company said in a release. The results were based on a composite measure from 8 a.m. through 8 p.m. on the Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) scale.
Those patients getting the drug also indicated improved functioning during their morning routine, which was the study's key secondary endpoint. The improvement in patient functioning during early day routines is currently being studied in more depth in a second pivotal study that is expected to be completed in the coming months.
"We currently believe that there is something unique happening at the dopamine neurotransmission level that may be attributed to a unique absorption profile, which will be the subject of an upcoming study," Dr. Bev Incledon, executive vice president of R&D at Highland subsidiary Ironshore, said in a statement. "This work will be important for the medical community to consider and will surely deepen our appreciation of the potentially critical role that pharmacokinetics have on the effectiveness of stimulant medications."
Additionally, the company said, the group given Benjorna also reported significant improvement in functioning in the evening. The extended duration of the drug was previously observed in a prior Phase III study conducted two years ago in which subjects showed improved functioning through to 8 p.m. the following day, the company said.
The control of ADHD symptoms in a delayed-release manner is a particular 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 in the pipeline.
- here's the release