TORONTO--(BUSINESS WIRE)--Highland Therapeutics Inc.’s wholly owned subsidiary, Ironshore Pharmaceuticals & Development, Inc. (“Ironshore”), today announced that the U.S. Food and Drug Administration (“FDA”) has provisionally accepted the Company’s request for the trade name Benjorna™ for its next-generation formulation of methylphenidate in development for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Benjorna™ was formerly referred to as HLD-200.
“The clinical development program for Benjorna™ is nearing completion, with top-line data from the first of two ongoing pivotal studies anticipated shortly,” said Tom Curatolo, Executive Vice-President, Commercial Strategy and Operations. “We believe Benjorna™, if approved, could represent a paradigm shift in the treatment of ADHD and look forward to bringing this important therapeutic option to the millions of families that struggle with the disorder.”
Benjorna™ is currently being studied in two ongoing pivotal trials, HLD200-107 and HLD200-108. HLD200-107 is a Phase III multicenter, open-label, treatment-optimized, double-blind, randomized, placebo-controlled, forced-withdrawal, parallel group study to evaluate the safety and efficacy of evening-dosed Benjorna™, in children aged 6-12 with ADHD in a laboratory classroom setting. The study has randomized 155 patients across seven centers in the U.S. Top-line data are anticipated shortly.
HLD200-108 is a Phase III multicenter, double-blind, randomized, placebo-controlled, parallel study designed to evaluate the safety and efficacy of Benjorna™ on post-waking, early morning function in children aged 6-12 with ADHD. The study will randomize approximately 150 patients across 22 centers in the U.S. Top-line results are anticipated in the second quarter of 2016.
Existing marketed treatments for ADHD are generally taken in the morning and can have a delay of up to two hours before onset of clinical effect is achieved, essentially leaving the patient in an un-medicated state during what is often the most chaotic time of day for families – the morning routine. Leveraging Ironshore’s proprietary DELEXIS® technology, Benjorna™ is designed to improve functioning and reduce ADHD symptoms during the morning routine. Importantly, given its long absorption window, Benjorna™ is designed to provide this coverage throughout the day.
About Highland Therapeutics Inc.
Highland Therapeutics Inc. is a specialty pharmaceutical company that, through its wholly owned subsidiary Ironshore Pharmaceuticals & Development, Inc., is leveraging its proprietary technology, DELEXIS®, to optimize the delivery of previously approved drug products. The Company’s lead product candidates, Benjorna™ and HLD-100, are novel formulations of the psychostimulants (methylphenidate and amphetamine, respectively) used to treat ADHD and are being developed to address a prevalent unmet medical need in the treatment of the disease – inadequate symptom control during the morning routine. Intended for nighttime dosing, DELEXIS® is designed to provide a consistent delay in the initial release of the active drug, followed by a period of extended release; with the objective of providing control of ADHD symptoms immediately upon wakening and throughout the day.
Highland Therapeutics Inc. is a client of MaRS Discovery District’s Health Venture Services group, which provides advisory services, connections to talent, customer & capital networks, and market intelligence to high-impact, Ontario-based life sciences ventures, helping them commercialize their ideas and build globally competitive companies.
For further information, please visit the Company’s website at www.highlandtherapeutics.com.
This press release contains forward-looking information, which reflects Highland’s current expectations regarding future events. Forward-looking information is based on a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond Highland’s control that could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking information. These forward-looking statements are made as of the date of this press release and, except as expressly required by applicable law, Highland assumes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.