CAMBRIDGE, Mass.--(EON: Enhanced Online News)--Neurovance, Inc. today announced acceptance of its Investigational New Drug (IND) application for EB-1020 SR by the US Food and Drug Administration and initiation of a phase 2a pilot study in adult patients with attention deficit hyperactivity disorder (ADHD). EB-1020 SR was designed for use in all subtypes of adult ADHD and is intended to show greater efficacy than atomoxetine, the only non-stimulant currently approved for adults today. EB-1020 SR has the potential for less abuse liability than the stimulants, the leading medications used to treat adults with ADHD. Patient recruitment is now underway in the phase 2a clinical trial, and top-line results are expected in early 2014.
“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”
The EB-1020-ADHD-201 trial is a US exploratory phase 2a flexible-dose study in 40 adult ADHD patients and is designed to establish the efficacy of doses ranging from 300 to 500 mg per day. It will be led by Dr. Andrew Cutler, a well-known expert in ADHD (see NCT01939353 at www.clinicaltrials.gov). The pilot study, the first in the US and the first in patients, follows two phase 1 studies conducted in Canada and Australia that established the safety, pharmacokinetics and tolerability of the molecule in healthy volunteers.
According to IMS Health, the US ADHD market in 2012 was valued at $10.4 billion with significant prescription growth coming from the adult segment of the market. Worldwide recognition and treatment of adult ADHD are expected to rise significantly during the next decade.
“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,” said Timothy Wilens, MD, of Massachusetts General Hospital and a leading ADHD expert. “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.”
EB-1020 SR modulates norepinephrine (NE), dopamine (DA) and to a lesser extent, serotonin (5-HT) reuptake inhibition in a ratio of 1 to 6 to 14, respectively. EB-1020 SR has a norepinephrine profile similar to the first-generation non-stimulant atomoxetine, but unlike atomoxetine, EB-1020 SR adds moderate dopamine and serotonin neurotransmission that is intended to improve efficacy as well as to potentially impact the co-morbidities associated with ADHD. The combination of norepinephrine and dopamine reuptake inhibition is believed to improve both focus and decision-making that are impaired in ADHD. The level of dopamine activity associated with EB-1020 SR is less than that of stimulants – an important distinction because stimulants may be addictive, leading to their designation as Schedule II controlled substances that are tightly regulated by the government. By contrast, EB-1020 SR may have a lower risk of drug abuse liability and diversion, as suggested by preclinical and clinical data to date.
Separately, Neurovance announced that Timothy Hsu, MD, has been appointed Chief Medical Officer. Dr. Hsu has more than 15 years of large pharma/biotech clinical development and medical affairs experience and over 30 years of expertise as a psychiatrist and internist. His experience covers approvals across a variety of CNS indications and all stages of drug development, including overseeing preclinical, clinical and post-approval programs, interpreting data for regulatory submissions, and leading discussions with international regulatory agencies.
“Tim has a number of pre-existing connections with us, especially at the investigator level, including previous collaborations with our principal investigator in the EB-1020 ADHD program, Dr. Andrew Cutler,” said Anthony A. McKinney, President and CEO of Neurovance. “Clinical development is an absolute priority in this organization and hiring someone with Tim’s broad experience in clinical development and regulatory affairs was ideal.”
About Neurovance, Inc.
Neurovance is a neuroscience-focused, clinical stage company developing next-generation treatment for ADHD. Neurovance is an affiliate of Euthymics, which is developing amitifadine, a triple reuptake inhibitor that acts on serotonin, norepinephrine and dopamine in a ratio of 1 to 2 to 8. Neurovance’s EB-1020 SR, a norepinephrine and dopamine-preferring triple with modest activity on serotonin, is being developed to treat adult ADHD with reduced risk of addiction, abuse and diversion. These companies have common headquarters in Cambridge, Massachusetts. Additional information can be found at www.euthymics.com.