Neurovance Inc. announced that it has completed enrollment in a human abuse liability (HAL) study of centanafadine (formerly EB-1020). Centanafadine is a novel non-stimulant being developed for the treatment of adults with attention deficit hyperactivity disorder (ADHD). Data from its pilot phase 2a efficacy study in adult ADHD presented at a scientific meeting earlier this year demonstrated efficacy in a range similar to stimulants. This new trial is designed to evaluate the abuse liability potential for centanafadine among recreational stimulant users. Results are expected during fall 2014.
“This is the second major advancement in the development of centanafadine for adult ADHD,” said Anthony McKinney, president and CEO of Neurovance. “First, centanafadine’s efficacy was demonstrated in a pilot study presented at the Society of Biological Psychiatry Annual Scientific Meeting in May. Now this substantial HAL study will test centanafadine’s abuse profile against two powerful stimulants and placebo. If this registration-level study confirms the preclinical data, we can be more confident that centanafadine has the potential for less restrictive scheduling than the stimulants currently used to treat ADHD.”
Neurovance expects to demonstrate that centanafadine SR, a norepinephrine- and dopamine-preferring triple reuptake inhibitor, has the right ratio for the right patient, without abuse liability. The HAL study is a five-arm clinical study designed to evaluate the abuse liability potential for centanafadine at two doses among qualified recreational stimulant users compared to Schedule II comparators d-amphetamine or lisdexamfetamine (Vyvanse) or placebo. The leading products for ADHD are stimulants, which are heavily restricted due to abuse liability. In preclinical testing, centanafadine did not show stimulant activity and it is expected to have reduced risk of abuse and diversion.
The HAL study was designed by a team of abuse liability testing experts at Altreos Inc. of Toronto and is being conducted by Vince & Associates Clinical Research of Overland Park, Kansas, a CRO with expertise in conducting complex clinical pharmacology studies.
Date: August 7, 2014
Filed Under: Drug Discovery