Effectiveness of Extended Release Single Dose Suspension of Methylphenidate for ADHD

Researchers have found oral administration of an extended release version of methylphenidate (NWP06) to be effective.

It’s clear that children and adolescents with attention-deficit/hyperactivity disorder (ADHD) have to stick to their medication regimens, but getting them to take pills a few times a day was difficult. In response, pharmaceutical companies developed once-daily extended release versions of the drugs, but even they could be a challenge for children and adolescents who would not, or could not, swallow pills.

But an extended-release suspension formulation could do the trick.

In a recent issue of Postgraduate Medicine, researchers from the Center for Psychiatry and Behavioral Medicine in Las Vegas reported that there were no age-related pharmacokinetic differences after oral administration of an extended release version of methylphenidate (NWP06) to children or adolescents in a small sample.

The researchers noted that currently, there is no extended-release liquid oral preparation of any stimulant, thus underscoring a medical need for a liquid extended-release preparation of methylphenidate for the management of ADHD in children who are unable or unwilling to swallow solid formulations.

For the study, the researchers evaluated the single-dose pharmacokinetics of an extended-release oral liquid formulation of methylphenidate (NWP06) in pediatric subjects with ADHD.

“Subjects with ADHD received a single oral dose of NWP06 20 or 60 mg. Serial blood samples were obtained before and after drug administration for determination of plasma methylphenidate concentrations and standard pharmacokinetic parameters. Dose- and weight-corrected pharmacokinetic parameters were presented by age group (9-12 years and 13-15 years),” they wrote in the study abstract.

The researchers enrolled a total of 14 youths (seven children aged nine-12 years and seven adolescents aged 13-15 years) and all completed the study. Their body mass index ranged from 12.08 to 34.08 kg/m(2).

“Mean values of dose and body weight-adjusted maximum plasma concentration (Cmax) (23.8, 22.3, 22.1, 25.7 [ng/mL]/mg) and area under the concentration-time curve (AUC) (208, 199, 239, 210 [hr•ng/mL]/[mg/kg]) were similar among all age/dose groups, suggesting dose proportionality and a similar rate and extent of absorption in children and adolescents,” the authors wrote.

Values for Cmax were observed between two and four hours after the dose, and the elimination half-life and body weight-adjusted clearance also appeared to be independent of dose and age. “NWP06 was well tolerated with no serious adverse events and no adverse event-related treatment discontinuations,” the researchers concluded.

SourceSingle-dose Pharmacokinetics of NWP06, an Extended-release Methylphenidate Suspension, in Children and Adolescents with ADHD [Postgraduate Medicine]