FDA Approves Methylphenidate PM Formulation for ADHD

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.

In the second study, patients reported improvements in manifestations through the day by the primary endpoint of ADHD-RS-IV scores, and improvements in manifestations prior to school via the BSFQ.

David Lickrish, president and chief executive officer of Ironshore, noted that other manufacturers have adjusted methylphenidate formulations to differ the ratio of immediate-release and extended-release features in ADHD medications.

“Our approach to drug development was to start from the desired pharmacokinetic profile and then work to develop a purpose-built technology capable of achieving that profile,” Lickrish said in a statement. “I believe that the unique DELEXIS® drug delivery platform is a disruptive technology that has many applications and opportunities in several therapeutic categories.”

Randy Sallee, MD, chief medical officer, echoed that early mornings are often the “most chaotic times of the day” in families with pediatric ADHD patients.

“The idea of dosing the medication the night before was our moon-shot solution to meeting this need,” Sallee said. “The approval of JORNAY PM is a welcome treatment option for healthcare providers, patients and their caregivers that may affect the way physicians think about ADHD treatment going forward.”