Alcobra files IND application for extended release metadoxine to treat ADHD patients

MG01CI (Metadoxine extended-release) is intended for the treatment of cognitive dysfunctions, such as attention deficit hyperactivity disorder (ADHD) and Fragile X Syndrome.

Principal investigator of the trial will be Dr Richard Weisler, an adjunct professor of psychiatry at the University of North Carolina (UNC) Chapel Hill School of Medicine, and adjunct associate professor of psychiatry and behavioral sciences at Duke University Medical Center in Durham, North Carolina.

The Phase III clinical trial will be carried out at about 20 additional clinical sites in the US and Israel.

Alcobra president and CEO Yaron Daniely said with the submission of this IND, the company has achieved an additional major milestone in its development program of MG01CI for ADHD and other cognitive disorders.

"Given the positive results in our two previous Phase II studies in adults with ADHD we look forward to working closely with the FDA to meet the remaining requirements necessary to bring this therapy to the market," Daniely said.

The trial is entitled "A 6-week Randomized, Multicenter, Double-blind, Parallel, Fixed-dose Study of MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg Compared with Placebo in Adults with Attention Deficit/Hyperactivity Disorder (ADHD)."

The company is mainly focused on the development and commercialization of a proprietary drug candidate, MG01CI, which had recently completed Phase II trials for the treatment of ADHD.

Image: Alcobra’s Phase III trial of its proprietary drug candidate MG01CI will be conducted at about 20 additional clinical sites in the US and Israel. Photo: courtesy of holohololand/ freedigitalphotos.net