Highland Therapeutics announces positive interim results of HLD-200 in ADHD patients

Highland Therapeutics Inc., a specialty pharmaceutical company leveraging its proprietary technologies to optimize the delivery of previously approved drug products, announced that its wholly owned subsidiary has generated positive interim Phase I/II results from an ongoing study of HLD-200 – a novel formulation of methylphenidate being developed to treat the symptoms associated with Attention-Deficit/Hyperactivity Disorder (ADHD). The study, “A Phase I/II, Single Center, Single-Treatment, Open-Label, Adaptive Clinical Trial Design Examining the Pharmacokinetic Effects of up to Two Separate HLD-200 Modified Release Formulations of Methylphenidate in Adolescent and Pediatric Subjects with Attention-Deficit Hyperactivity Disorder”, is expected to be completed in the fourth quarter of 2013. Based on an interim analysis of data from adolescent patients, the study demonstrated that the active pharmaceutical ingredient (API), methylphenidate, was consistently delivered in a manner that allows for dosing of HLD-200 prior to bedtime, with the objective of controlling the symptoms of ADHD immediately upon wakening. Further, a comparative analysis of the pharmacokinetic (PK) profiles suggests that HLD-200 could have an extended duration of effect when compared to other once-daily methylphenidate medications. Notably, patients enrolled in the study did not report any significant adverse events, which suggests that HLD-200 could potentially have a better safety profile than other available medications to treat ADHD.