- NLS-1 (mazindol CR) is not a stimulant, yet yields large effect size of 1.09 (using the ADHD-RS-DSM-5 scale)
- 55% of patients in NLS-1 (mazindol CR) arm had ADHD symptoms reduced by ≥50%, as measured by ADHD-RS-DSM-5 score, compared to 15.8% for placebo
- An awakeness regulator, NLS-1 (mazindol CR) has a mechanism-of-action that differs from both stimulants and non-stimulants
- No serious treatment-related adverse events were observed in the study, and no discontinuation of NLS-1 (mazindol CR) by study participants
- A Schedule IV substance, NLS-1 (mazindol CR) provides the potential for more prescription flexibility with minimal risk of misuse, diversion
STANS, Switzerland and MIAMI, May 31, 2017 /PRNewswire/ -- NLS Pharma Group (NLS Pharma), a Swiss biotech group focusing on the development of novel treatments for attention deficit hyperactivity disorder (ADHD), sleep disorders, and cognitive impairments, today announced positive clinical data from the Phase 2 study of its lead compound, NLS-1 (mazindol CR), as a potential novel option for the treatment of ADHD in adults. NLS-1 (mazindol CR), which is not a psychostimulant, met both the primary and secondary endpoints in this double-blind, placebo-controlled study, while yielding an effect size of 1.09 (using the ADHD-RS-DSM-5). Among study subjects randomized to the NLS-1 (mazindol CR) treatment arm, most experienced greater than 50% reduction in ADHD symptoms with 70% achieving 30% improvement, relative to 21% achieving 30% reduction in the placebo arm.
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"These data are remarkable, and especially striking because NLS-1 (mazindol CR) is not classified as a stimulant," said Tim Wigal, PhD of AVIDA, Inc., in Newport Beach, CA, coordinating investigator for the study. "The large effect size of 1.09 was achieved with a maximum 3 mg dose of NLS-1 (mazindol CR) and without any treatment-related discontinuations. Should a pivotal trial deliver a replication of these results, NLS-1 (mazindol CR), if approved, may be a significant advance in ADHD treatment."
"As an investigator in ADHD research for over 20 years, I believe that these data, are the best one could reasonably hope for in a Phase 2 study," said Gregory W. Mattingly, MD, NLS-1001 investigator and Associate Clinical Professor, Washington University School of Medicine, St. Louis, MO. "Every efficacy measure clearly separated from placebo, side effects were very well tolerated and the effect size of 1.09 is outstanding. Of great importance, patients observed that they were doing better in their daily lives. If NLS-1 (mazindol CR) advances to approval in ADHD, its less-restrictive Schedule IV classification could also be more convenient for patients."
The NLS-1001 study (NCT 02808104) evaluated NLS-1 (mazindol CR) in 85 adult patients with ADHD over 6 weeks of treatment at seven U.S. sites. 43 patients were randomized to the NLS-1 (mazindol CR) arm (N=43) with 42 subjects randomized to the placebo arm (N=42). The primary endpoint was defined as change from baseline in the Total ADHD-RS-DSM-5 score in the intent-to-treat (ITT) population at Day 42 (week 6), using a repeated–measures, mixed-effects model. Secondary endpoints were responder analysis and the Clinical Global Impressions Scale (CGI) weekly rating up to 6 weeks. Patients in the NLS-1 (mazindol CR) arm were dosed NLS-1 (mazindol CR) once daily, starting at 1 mg, increasing or decreasing in increments of 1 mg depending on the investigator's judgement regarding efficacy and tolerability, up to a maximum of 3 mg once daily. Specific results include:
The mean change from baseline in the ADHD-RS-DSM-5 score at Day 42 was statistically in favor of NLS-1 (mazindol CR) (P˂0.001).
Least Square (LS) mean improvements relative to baseline were -18.9 (NLS-1 (mazindol CR)) and -5.7 (placebo).
A significantly higher number of subjects were responders to NLS-1 (mazindol CR) vs placebo from Day 14, using a reduction of >50% in the ADHD-RS-DSM-5 as a cutoff.
At Day 42, 55% of NLS-1 (mazindol CR)-treated subjects had a reduction of >50% in ADHD-RS-DSM-5 score compared to 15.8% of placebo-treated subjects (P=0.002). Significant differe...
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