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New Drug Formulation Calms ADHD Kids in the AM and All Day Too

Research indicates that time processing is altered in children with ADHD, and their ability to stay task-focused through the normal series of morning routines is largely impaired.

Jornay PM is a novel, extended-release formulation of methylphenidate (better known as Ritalin and similar drugs). This medication is different from other formulations because it is given at bedtime instead of in the morning — a dosing difference that may totally change stressful and chaotic morning patterns most ADHD kids still experience.

With previous medications, the therapeutic window was shorter, and the drugs were scheduled to provide the most benefits during school hours. More recent extensions of therapy have led to better functioning after school as well. But since children didn’t take their medication until the morning, those hours before school remained a deep hole of stress, anxiety, and chaos in their households.

Ironshore Pharmaceuticals invested in exploring this troublesome territory and found that 91% of caregivers reported early morning as the time when ADHD symptoms were most significant, and 48% admitted to getting up early to administer their child’s ADHD meds.

Research indicates that time processing is altered in children with ADHD, and their ability to stay task-focused through the normal series of morning routines is largely impaired. ADHD kids have trouble moving from one event to the next in the morning, starting with waking up. They often have to be roused from bed repeatedly before they get up and then require constant reminders to get dressed, brush their teeth and wash up, sit down to breakfast, and collect their things for school to get out the door on time. This kind of early morning functioning (EMF), it turns out, requires a unique set of organizational skills. Unfortunately, in ADHD, those skills are significantly hampered by the traditional dosing of methylphenidate.

That gave Ironshore its “aha moment” when the company realized the unmet need for an ADHD medication that managed ADHD symptoms all day — from wake-up to evening. Using their proprietary DELEXIS® drug delivery platform, they developed Jornay PM with two functional film coatings. The first act is to delay the initial release of the drug for up to ten hours so that it can be taken at bedtime with no waste of medication. The second layer allows for a controlled release of the active drug throughout the day.

The efficacy of once-daily evening dosing of Jornay PM was demonstrated in two, phase three, randomized, double-blind, placebo-controlled trials in 278 children aged six to 12 years. These studies showed improved daytime control of symptoms with the addition of morning preschool times for an extended 12-hour symptom control window from 8 AM to 8 PM.

Clinical trials of methylphenidate, a CNS-stimulating drug, previously established the side effects profile. Jornay PM is contraindicated in children with a known hypersensitivity to methylphenidate or other drug components and in those who have taken an MAO inhibitor within the past 14 days.  

As with all CNS stimulant drugs, serious side effects include sudden cardiac death, blood pressure, and heart rate increases, psychotic or manic symptoms, priapism, peripheral vasculopathy, and long-term suppression of growth. Projected adverse reactions to Jornay PM (based on accumulated data from previous trials of methylphenidate drugs) include appetite decreases, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decrease, anxiety, dizziness, irritability, affect lability, tachycardia, and increases in blood pressure.

For further information, consult the complete prescribing information for Jornay PM here.

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