Investigational New Drug Newly Accepted for Phase II Study in Adults with ADHD May Later Be Tested for Narcolepsy

The FDA has accepted an investigational new drug (IND) submitted by Swiss biotech group NLS Pharma for a phase II proof-of-concept clinical trial evaluating the use of Mazindol in adults with attention deficit hyperactivity disorder (ADHD).

The lead investigator of the double-blind placebo-controlled Phase II study is Tim Wigal, PhD. Wigal has been author or co-author of over 125 peer-reviewed articles about ADHD and related disorders. Seven clinical sites in the USA have been selected to participate in the study.

Alex Zwyer, CEO of NLS Pharma says in a release: “The FDA’s acceptance of our first IND marks a major development milestone for our novel compound NLS-1 to treat ADHD. It allows us to commence our US-based Phase II study in adult patients with ADHD, and we expect to enroll the first patients this summer. The IND will also pave the way for additional studies for other related indications, including narcolepsy, a life-long and rare sleep disorder.”