FDA accepts Neurovance’s IND application for ADHD drug

24th September 2013 (Last Updated September 24th, 2013 18:30)

The US Food and Drug Administration (FDA) has accepted Neurovance's investigational new drug (IND) application for EB-1020 SR, a norepinephrine and dopamine-preferring triple reuptake inhibitor.

The US Food and Drug Administration (FDA) has accepted Neurovance's investigational new drug (IND) application for EB-1020 SR, a norepinephrine and dopamine-preferring triple reuptake inhibitor.

EB-1020 SR is being developed to treat all subtypes of adult attention deficit hyperactivity disorder (ADHD) with reduced risk of addiction, abuse and diversion.

Neurovance has also started a Phase IIa study in adult patients with ADHD and results from this trial are anticipated to be revealed in early 2014.

The EB-1020-ADHD-201 trial, a US exploratory Phase IIa flexible-dose study, which will be conducted in 40 adult ADHD patients, will focus on establishing the efficacy of doses ranging from 300mg to 500mg per day.

Claimed to be the first in the US and the first in patients, the study follows two Phase 1 studies conducted in Canada and Australia.

"Only a minority of adults with the disorder solely have the core symptoms of ADHD so a product like EB-1020 SR could be a major advance in the field."

The safety, pharmacokinetics and tolerability of the molecule in healthy volunteers was established in previously conducted Phase I clinical studies.

ADHD expert Timothy Wilens said EB-1020 SR has the potential to treat adults with ADHD with the co-morbidities that affect the majority of adults with ADHD including depression, anxiety and even substance abuse.

"Only a minority of adults with the disorder solely have the core symptoms of ADHD so a product like EB-1020 SR could be a major advance in the field," Wilens said.

According to the company, EB-1020 SR adds moderate dopamine and serotonin neurotransmission improves efficacy and potentially impacts the co-morbidities associated with ADHD.

In addition, EB-1020 SR is expected to have a lower risk of drug abuse liability and diversion as the level of dopamine activity associated with it is less than that of the stimulants.

Neurovance is an affiliate of Euthymics, which is currently developing amitifadine, a triple reuptake inhibitor that acts on serotonin, norepinephrine and dopamine in a ratio of 1 to 2 to 8.