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FDA accepts IND for mazindol for adult ADHD
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The FDA recently accepted an investigational new drug submitted by NLS Pharma for mazindol, a norepinephrine and dopamine reuptake inhibitor, to treat attention-deficit/hyperactivity disorder in adults.
Mazindol was previously approved in Europe and the U.S. as an immediate-release formulation for obesity.
An open-label trial of mazindol showed efficacy for pediatric ADHD. As a result, NLS Pharma is developing a controlled-release formulation to potentially treat ADHD in adults.
A double-blind, placebo-controlled, phase 2 study in adults will be conducted by Tim Wigal, PhD, of the University of California, Irvine, across seven clinical sites in the U.S.
“The FDA’s acceptance of our first IND marks a major development milestone for our novel compound NLS-1 to treat ADHD,” Alex Zwyer, MBA, CEO of NLS Pharma, said in a press release. “It allows us to commence our U.S.-based phase 2 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.” – by Amanda Oldt