NLS Pharmaceutics Receives Green Light from the U.S. Food and Drug Administration to Proceed with Phase 3 Clinical Program for Quilience(R) for the Treatment of Narcolepsy

NLS Pharmaceutics Ltd. announced that the U.S. Food and Drug Administration (FDA) provided authorization to proceed with the Phase 3 program for Quilience® (Mazindol ER). The AMAZE Program will encompass two double-blind Phase 3 trials (N=50 each) investigating Mazindol ER versus placebo in adult patients with narcolepsy, commencing this summer at multiple sites in the U.S. Both phase 3 trials, NLS-1031 and NLS-1032, will measure the weekly cataplexy episodes as the primary endpoint over 8 weeks of treatment. To be eligible for enrollment into the program, patients must be at least 18 years of age and have been diagnosed with narcolepsy with cataplexy.

Data from the Phase 2 studies will be presented at SLEEP 2023, the annual meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS), which is being held from June 3 - 7, 2023, in Indianapolis.