Promising Medication Tested Successfully on Adults with ADHD
The nonstimulant medication mazindol CR, previously approved in Europe for sleep disorders and obesity, has undergone a preliminary U.S. trial wherein the majority of subjects experienced improved symptoms of ADHD.
June 9, 2017
The Switzerland-based company NLS Pharma has announced positive results for its Phase II trial of mazindol CR, a nonstimulant medication in development now for treating children and adults with ADHD. If Phase III trials follow suit, it will face FDA approve in the next few years.
Mazindol CR, also known as NLS-1, was tested on 85 adult patients with ADHD. The double-blind, placebo-controlled trial lasted six weeks, and found that 55 percent of patients taking mazindol CR said their ADHD symptoms decreased by at least 50 percent. Seventy percent noticed a 30 percent decline in symptoms. And only 21 percent of the patients taking a placebo reported symptom improvements of 30 percent or greater, making mazindol CR’s results statistically significant, the researchers said.
Side effects were “very well-tolerated,” said Gregory Mattingly, M.D., an investigator on the study. However, the company’s press release did not elaborate on the exact type and number of side effects. The medication demonstrated positive effects within one week, researchers said; other nonstimulants can take up to six weeks to impact ADHD symptoms.
Today, most patients with ADHD take methylphenidate or amphetamine, stimulants that are not well tolerated by everyone with the condition. Mazindol CR’s positive results may open up a new nonstimulant treatment option for these patients, the researchers said.
“Should a pivotal trial deliver replication of these results, NLS-1 (mazindol CR), if approved, may be a significant advance in ADHD treatment,” said Tim Wigal, Ph.D., coordinating investigator for the trial.
Mazindol CR was previously approved in Europe as a treatment for sleep disorders or obesity, however it proved unpopular because its anti-obesity effects slowed down after a few weeks. Mattingly insists this is a benefit for its use as an ADHD medication.
“For an ADHD medication, that’s exactly what you want,” he said. “You don’t want one that keeps causing weight loss and people keep trying to use it for issues other than what they should be using it for, which is cognition.”
The medication will enter Phase III trials next. If results are positive, it will be up for approval by the FDA.