US-based neuroscience-focused firm Neurovance has completed patient enrolment in a human abuse liability (HAL) study of centanafadine (formerly EB-1020), a new non-stimulant being developed for the treatment of adults with attention deficit hyperactivity disorder (ADHD).
According to the company, data from its pilot Phase IIa efficacy study in adult ADHD showed efficacy in a range similar to stimulants.
The HAL study will evaluate the abuse liability potential for centanafadine among recreational stimulant users and results are scheduled to be reported during the autumn of 2014.
Neurovance president and CEO Anthony McKinney said: "This is the second major advancement in the development of centanafadine for adult ADHD.
"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 intends to show that centanafadine SR, a norepinephrine and dopamine-preferring triple reuptake inhibitor, has the right ratio for the right patient, without abuse liability.
The five-arm HAL study is designed to assess the abuse liability potential for centanafadine at two doses among qualified recreational stimulant users compared to Schedule II comparators d-amphetamine, lisdexamfetamine (Vyvanse) or placebo.
The trial was designed by a team of abuse liability testing experts at Altreos and is being carried out by Vince & Associates Clinical Research of Overland Park, a contract research organization (CRO).