Mid-stage data show promise for mazindol C-R

Swiss biotech firm NLS Pharma says that its double-blind placebo-controlled Phase II study with a controlled-release (CR) formulation of mazindol in adults with DSM-5 attention deficit hyperactivity disorder (ADHD), NLS-1001, has met its primary and secondary endpoints.

“The promising results of NLS-1, our lead ADHD compound, in the Phase II study are very encouraging and demonstrate the potential for mazindol CR (NLS-1) to make a difference in the lives of patients suffering from ADHD across the world,” said Alex Zwyer, chief executive of NLS Pharma.

NLS Pharma is investigating NLS-1 as a potential alternative to conventional first-line treatments in ADHD. Drug discovery scientists at NLS Pharma hypothesize that the performance exhibited by NLS-1 in the Phase II trial may be explained by the molecule’s unique mechanism of action (MoA) in potentially regulating the orexins system in the hypothalamus. The clinical potential of mazindol to improve ADHD symptoms was first observed in an open label pilot study which assessed the efficacy, safety and pharmacokinetics of mazindol in children with ADHD (MAZDAH study).