US-based, clinical stage, neuroscience-focused company Neurovance has reported a positive outcome for the Phase IIb trial of centanafadine SR (CTN) to treat adults with attention-deficit / hyperactivity disorder (ADHD).
CTN is a non-stimulant controlling the activity of norepinephrine (NE), dopamine (DA) and serotonin (5-HT), three neurotransmitters considered to be responsible for the disorder.
The Phase IIb trial was a placebo-controlled crossover study conducted over a period of three weeks.
A total of 85 adult ADHD patients were involved in the trial and administered with CTN on a twice daily regimen.
The trial was designed to determine the safety and efficacy of CTN in treating ADHD.
Results displayed that CTN had the same effect as a non-stimulant when compared with the effects of the approved stimulants.
The 400mg dosage of CTN has also demonstrated tolerability with lesser rates of insomnia and loss of appetite when compared with stimulants.
Neurovance 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.”
Based on the data from the Phase II trial, the company is planning to conduct the Phase III trial of CTN to support the US Food and Drug Administration (FDA) approval.