FDA approves Jornay PM to treat ADHD symptoms.- Ironshore Pharma & Development Inc.
Ironshore Pharmaceuticals & Development, Inc. a wholly owned subsidiary of Highland Therapeutics Inc. has announced that the FDA has approved the New Drug Application(NDA) for Jornay PM (methylphenidate) (formerly known as HLD200) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.
Jornay PM is a novel formulation of methylphenidate which is taken in the evening and has demonstrated improvement in the severity of ADHD symptoms in the early morning and throughout the day. Jornay PM is the first drug utilizing Ironshore�s proprietary drug delivery platform, DELEXIS. Ironshore plans to initiate the commercial launch of Jornay PM in the first half of 2019.
The effectiveness of JORNAY PM was established in two separate Pivotal Phase III, multicenter, randomized, double-blind, placebo-controlled studies conducted in a total of 278 pediatric patients aged 6 to 12 years with a diagnosis of ADHD per DSM-5 criteria. In addition to the traditional scales that assess efficacy in ADHD clinical trials such as the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale and the ADHD Rating Scale (ADHD-RS-IV). Ironshore�s pivotal trials assessed JORNAY PM�s efficacy in the early morning period using the morning subscale of the Parent Rating of Evening and Morning Behavior-Revised (PREMB-R AM) scale and the Before School Functioning Questionnaire (BSFQ).
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