FDA Oks Methylphenidate PM Formulation for ADHD in Patients Aged 6 and Up

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The US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for methylphenidate (JORNAY PM) as a therapy for pediatric patients with attention deficit hyperactivity disorder (ADHD).

The Ironshore Pharmaceuticals & Development therapy, formerly known as HLD200, is a novel methylphenidate formulation indicated for evening administration in patients with ADHD aged 6 years and older.

As a PM therapy, it has shown improvement in the severity of ADHD symptoms in the early morning and throughout the day for patients. Its commercial launch is anticipated in the first half of next year.

The methylphenidate formulation’s efficacy was established in a pair of pivotal phase 3, multicenter, randomized, double-blind, placebo-controlled trials featuring 278 pediatric patients aged 6-12 years old with an ADHD diagnosis. Researchers assessed the drug’s efficacy using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale, the ADHD Rating Scale (ADHD-RS-IV), as well as the Parent Rating of Evening and Morning Behavior-Revised (PREMB-R AM) scale and the Before School Functioning Questionnaire (BSFQ)—the latter 2 emphasizing its utility as a PM therapy.

In the first study, when assessing for a primary endpoint of post-dosed SKAMP combined scores measured during a 12-hour period, patients reported improvements in ADHD manifestations in a classroom setting. Patients also reported improvements in manifestations in the early morning by PREMB-R AM.

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