Neurovance’s centanafadine ADHD drug meets main goals in phase 2b trial

Neurovance said that CTN was within the range of the pivotal trials of approved stimulants, with a 400 mg sample of the drug demonstrating an effect size of 0.6 – a value that has matched the effect sizes of the most commonly prescribed ADHD medications in the US.

The 400 mg dose was generally well tolerated with rates of insomnia and loss of appetite less than typically seen with stimulants, the company added.

The phase 2b trial of centanafadine SR was a placebo-controlled crossover which lasted for weeks and was conducted on 85 adult ADHD patients.

As per the trial records, patients who received CTN 400 mg had a -15.1 point change from baseline in the primary endpoint when compared to a -8.1 point change observed with placebo thereby resulting in a difference of -7.0 along with an effect size of 0.6.

The drug mechanism involves modulation of norepinephrine , dopamine  and serotonin, which are believed to be the key neurotransmitters involved in ADHD.

A total of 7 human trials have bee undertaken with centanafadine, five phase 1 studies and two phase 2 ADHD trials.

Neurovance co-founder, president and CEO, Anthony McKinney said: “We believe that CTN is among the first of a new generation of triple reuptake inhibitors in advanced development for ADHD and these study results are critical to establishing the dose range and regulatory path forward for centanafadine.

“Based on previous data we have shown, CTN had an efficacy profile approaching that of stimulants yet with human trial results suggesting less risk of abuse. We will use the data from this trial to support an FDA regulatory package with the goal of initiating phase 3 trials in early 2017.”

Neurovance executive chairman Jeff Bailey said: ““If approved, CTN has the potential to be the go-to drug for payers and doctors when patients do not respond well to first-line stimulants.”