The trials assessed the safety, efficacy and tolerability of centanafadine to treat adolescents and children with attention-deficit/hyperactivity disorder. Credit: MIA Studio / Shutterstock.com.

Otsuka Pharmaceutical has reported positive data from two Phase III clinical trials of its investigational compound, centanafadine, to treat attention-deficit/hyperactivity disorder (ADHD).

The randomised, three-arm, double-blind, fixed-dose, six-week pivotal trials assessed the safety, efficacy and tolerability of centanafadine to treat ADHD in adolescents and children.

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The first trial was conducted in adolescents aged 13 to 17 years while the second trial was carried out in children aged six to 12 years.

In both trials, participants were randomised to receive either low-dose or high-dose centanafadine or placebo.

The variation in the ADHD Rating Scale (ADHD-RS-5) symptoms total score from baseline to week six was the trials’ primary outcome.

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Findings showed that both trials met the primary endpoint and demonstrated improvements from baseline on the ADHD-RS-5 scale.

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All patients in the high-dose and low-dose centanafadine arms of these studies showed improvements versus placebo.

Furthermore, in both trials, the low-dose centanafadine-treated did not attain statistical significance.

Nausea, decreased appetite, fatigue, rash, pain in the upper abdomen and sleepiness were the most commonly reported side effects linked to treatment with centanafadine.

The safety and tolerability profile of centanafadine from these trials were in line with those reported in wider clinical development programmes.

Centanafadine is a norepinephrine, dopamine, and serotonin reuptake inhibitor.

Otsuka pharmaceutical development and commercialisation executive vice-president and chief medical officer John Kraus said: “Otsuka is committed to finding novel solutions for complex, underserved medical needs.

“We are pleased these pivotal Phase III results demonstrate centanafadine has the potential to offer a new treatment option for children and adolescents who live with ADHD, a condition that can affect every aspect of life.”