NLS Pharma Announces Start of Its Phase 2 Trial for Mazindol in Adult ADHD Patients

PRNewswire: August 29, 2016 – STANS, Switzerland, Aug. 29, 2016 – NLS Pharma Group (NLS) announced today that it has initiated enrollment for its “Double-Blind Placebo-Controlled Phase II Study to Determine the Efficacy, Safety, Tolerability and Pharmacokinetics of a Controlled Release (CR) Formulation of Mazindol in Adults with DSM-5 Attention Deficit Hyperactivity Disorder (ADHD)”.

“The first patient in marks an important milestone in the development of a non-amphetaminic stimulant for ADHD,” said Alex Zwyer, CEO at NLS Pharma Group.

Mazindol is a wake-promoting agent, a norepinephrine and dopamine reuptake inhibitor that was previously approved as an immediate release (IR) formulation in Europe and in the United States for the short-term treatment of obesity. It was taken off the market for reasons unrelated to its efficacy and safety. Rebalancing dysfunctional central nervous system (CNS) noradrenergic and dopaminergic systems appears to be critical for the effective treatment of ADHD and narcolepsy. Given that the central nervous system (CNS) noradrenergic and dopaminergic systems appear to be dysfunctional in ADHD and that an open-label trial of mazindol demonstrated efficacy in improving the symptoms of pediatrics with ADHD, NLS is developing a controlled release (CR) formulation of mazindol to potentially treat this disorder.

The principal investigator of the study is Dr. Tim Wigal, who brings extensive experience in clinical research, diagnosis, and treatment of ADHD to the project. Dr. Wigal has been author or coauthor of over 125 journal articles about ADHD and related disorders. Seven clinical sites in the United States will participate in the study.

“As only a fraction of adults with ADHD are being treated with traditional stimulants, it is clear that alternatives are needed. ADHD can affect numerous aspects of a patient’s life, and the current phase II study is examining functional outcomes in order to determine the impact of treatment,” according to Dr. Tim Wigal, lead investigator. “Depending on the results in adults, this line of research may quickly expand to include younger patients.”

Nelson Handal, MD, chief medical officer of NLS, said, “Clinicians and patients need effective and tolerable nonstimulant alternative medications to treat ADHD. Additionally, at-risk populations need safe and nonaddictive treatment options. This study creates a unique opportunity for the safe and successful treatment of ADHD in adults.”

NLS Pharma (NLS) is a Swiss-based biotech group focusing on the repurposing of established and (cost-) effective drug/chemical compounds to treat ADHD, sleep disorders, and cognitive impairment.

NLS is a fully privately owned enterprise managed by a top-level team of experts who have demonstrated their value and experience with Big Pharma companies. They work closely with renowned ADHD and sleep-related disorders opinion leaders.

On July 11, 2016, NLS announced that the U.S. Food and Drug Administration (FDA) had granted Orphan Drug Designation (ODD) for mazindol for the treatment of narcolepsy. On October 9, 2015, an ODD was granted by the European Commission to NLS for mazindol within the same indication. Series A financing was successfully completed on August 31, 2015, to secure full development of NLS-1 (mazindol) up to proof-of-concept in ADHD.