NLS Pharmaceutics AG (NASDAQ: NLSP) in its latest announcement, made it official that the U.S. Food and Drug Administration (FDA) has accepted the company’s recently filed application. The new drug application is about (IND) for Quilience® (mazindol extended-release, or mazindol ER). According to sources, the same is the company’s lead drug candidate that is widely used in the treatment of narcolepsy.
The proposed study will be initiated in August 2021
If all falls in place, the proposed medical study is all set to begin in August 2021. According to company sources, the study will be conducted in both the U.S. and Europe. According to sources, as many as 60 patients will be enrolled in the study.
Change from baseline in excessive daytime sleepiness (EDS) is the primary endpoint in the study. The shift from baseline in the mean weekly number of cataplexy attacks, a common condition in patients suffering from cataplexy, is the key secondary endpoint in the study.
Chief Executive Officer of NLS Pharmaceutics AG comments on the study
“We are pleased to now have an open IND so that we can initiate our clinical program with Quilience®, our novel formulation of mazindol ER, for the treatment of narcolepsy,” said Alex Zwyer, Chief Executive Officer of NLS. “We remain on track to commence our prospective Phase 2a clinical trial for Quilience® next month as we focus on bringing this treatment option to patients suffering from narcolepsy as soon as possible.”
NLS Pharmaceutics AG is a clinical-stage pharmaceutical company based out of Switzerland. The company works on designing and developing innovative therapies for patients suffering from not-so-common and complex central nervous system disorders.
Quilience® is the company’s lead product candidate. The product is being developed to treat narcolepsy. In addition, NLS Pharmaceutics AG completed its phase 2 study in the U.S. to evaluate its other mazindol-based drug candidate, Nolazol®. Adults with ADHD participated in the trial. The study was successful as it met the primary and secondary endpoints. Subsequently, as Quilience® was well-tolerated, it received a nod from the Orphan Drug Designations to treat narcolepsy in both the U.S. and Europe.