MADISON, Wis., Aug. 4, 2015 /PRNewswire/ -- Ironshore Pharmaceuticals & Development, Inc. ("Ironshore") has signed an agreement with Restore Health, a company specializing in personalized medicine, to participate in the fulfillment of a double-blind clinical trial, designed to evaluate the safety and efficacy of HLD-200, a new drug in development to treat Attention-deficit/hyperactivity disorder (ADHD). This is Restore's second clinical trial program with Ironshore.
Restore Health originally partnered with Ironshore in 2014 and continues to work with other development-stage companies nationally and internationally. Shara Rudner, RPh., FIACP, FACA, Director, Clinical Trials Group said, "It is an honor to host innovative pharmaceutical and development groups such as Ironshore. We strive to exceed expectations for all clinical trial requirements."
The initial Ironshore trial, completed in 2014, successfully met its primary endpoint, which demonstrated that administration of HLD-200 in the evening improves control of ADHD symptoms in pediatric subjects, as compared to placebo, the following day.
"We are pleased to be partnering with Restore Health for a second time, given their demonstrated ability to manage the complexity of dosing assignments and the logistics of a multi-site trial, and to maintain strict controls according to DEA requirements," said Jill Kapuscinski ,Vice President of Pharmaceutical Operations. "Ironshore is committed to developing a portfolio of products to help improve the quality of life of patients and families that struggle with ADHD."
"Our agreement with Ironshore and continued clinical trial work furthers Restore's mission to accelerate the availability of novel therapies, from 'bench to bedside,' " said Murray I. Firestone, Ph.D., President of Restore Health.
CONTACT: Jessica Reilly, 800-558-7046, email@example.com
About Restore Health
Restore Health is the first trusted national brand wholly dedicated to bringing personalized and specialty medicines to healthcare providers throughout the United States. Its unique full-service solution offers physicians integrated support of custom pharmacy, diagnostic laboratory, and clinical liaison personnel. Since 1982, Restore Health has established a reputation among physicians for providing personalized medications and guidance that truly make a difference in their patients' lives.
About Ironshore Pharmaceuticals & Development, Inc.
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, HLD-200 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.
SOURCE Restore Health